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Home My WebLink About20131118.tiffRESOLUTION RE: APPROVE TASK ORDER CONTRACT FOR TITLE X FAMILY PLANNING PROGRAM AND COLORADO FAMILY PLANNING INITIATIVE 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 Title X Family Planning Program and the Colorado Family Planning Initiative between the County of Weld, State of Colorado, by and through the Board of County Commissioners of Weld County, on behalf of the Weld County Department of Public Health and Environment, and the Colorado Department of Public Health and Environment, commencing June 30, 2013, and ending, June 30, 2014, 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 Title X Family Planning Program and the Colorado Family Planning Initiative between the County of Weld, State of Colorado, by and through the Board of County Commissioners of Weld County, on behalf of the Weld County 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. BE IT FURTHER RESOLVED by the Board that the Weld County Department of Public Health and Environment be, and hereby is, directed not to dispense Plan B One -Step, and to instead provide counseling and referral to alternative community agencies which will provide Plan B One -Step for clients who choose to utilize this method of contraception. /IL 7-1/-,OW4.3 2013-1118 HL0040 TASK ORDER CONTRACT FOR TITLE X FAMILY PLANNING PROGRAM AND COLORADO FAMILY PLANNING INITIATIVE PAGE 2 The above and foregoing Resolution was, on motion duly made and seconded, adopted by the following vote on the 6th day of May, A.D., 2013. BOARD COUNTY COMMISSIONERS WE"7/"Y, COLORADO ATTEST: Weld County Clerk to the Board BY: Deputy Clerk APP the Board ty Attorney Date of signature: Barbara Kirkmeyer William F. Garcia, P. Conway e Freeman EXCUSED 2013-1118 HL0040 WELDL-COUNTY u Memorandum TO: William F. Garcia, Chair Board of County Commissioners FROM: Mark E. Wallace, MD, MPH, Director Department of Public Health and Environment DATE: 3-22-2013 SUBJECT: Family Planning Program Task Order Contract FY 2013-2014 combined with Colorado Family Planning Initiative Task Order Contract FY 2013-14 Enclosed for Board review and approval is a Task Order Contract between the Colorado Department of Public Health and Environment and the Weld County Board of County Commissioners on behalf of the Department of Public Health and Environment (WCDPHE) for continuation of a comprehensive family planning program. Under the provisions of this contract, WCDPHE will continue providing comprehensive family planning services to men and women in their reproductive years. These services will include comprehensive health and social histories, physical examinations, contraceptive information and supplies. Education and counseling regarding all family planning methods, infertility, sterilization, nutrition, sexually transmitted disease, follow-up and/or referrals will also be provided. For the above services, Weld County will be reimbursed an amount not to exceed $193,008. This represents the combined funding from the Title X (Federal and State) funding plus the Colorado Family Planning Initiative (private donor funding for Long Acting Reversible Methods LARC) funding. The term of the contract is from July 1, 2013, through June 29, 2014. I recommend your approval of this Task Order Contract. Enclosure 2013-1118 DI:I'ARTMI NI OF PUBLIC I Il AL II AND ENVIRONMENT ROUTING NO. 13 FLA 55556 APPROVED TASK ORDER CONTRACT — WAIVER #154 This Task Order Contract is issued pursuant to Master Contract made on 01/17/2012, with routing number 13 FAA 00051. State of Colorado for the use 8c benefit of the Department of Public Ilealth and Environment Prevention Services Division 4300 Cherry Creek Drive South Denver, Colorado 80246 TASK ORDER MADE: DA IP:. 4/23/2013 PO/SC ENCUMBRANCE. NUMBS R_ PO FLA PSD1355556 I LAM. This Task Order shall be effective upon approval by the State Controller, or designee, or on 06/30/2013, whichever is later. The Task Order shall end on 06/30/2014. I'RICE. S1' RUCi L PL. Cost Reimbursement 'HOCC RIIIM I NT MI. IHOD: Exempt BID/ RFT/ DS I PRICE AGRI:FMF.NI NUMBER: Not Applicable I A\X SPFCI H HD VENDOR S FATCIE1 Not Applicable STATE REPRESENTATIVE: Greta Klingler or Jody Camp Department of Public Health And Environment PSD-FPP 4300 Cherry Creek Drive South Denver, Colorado 80246 SCOPE OF IX' IRK: CONIRACCOR_ Board of County Commissioners of Weld County (a political subdivision of the state of Colorado) 915 10th Street Greeley, Colorado 80632-0758 for the use and benefit of the Weld County Department of Public Health and Environment 1555 North 17th Avenue Greeley, Colorado 80631 CON 'IRAC 1 OR FIST Fly l Foh: Colorado BILLING STATEMENTS RECEIVED, Monthly 51 Alt T( Orr Al;I'HORII$ Not Applicable Political Subdivision CON I IRAC I PRICE NOI lU EXCF.IID_ 5193,008.00 PI(DIIIUM, FUNDING DOI .I.ARS. SIlA II: I I: NI)ING 1)011 AR', $ 105,774.00 $ 45,210.00 PRI VA II. It NDING DOLLARS $ 42,024.00 MAXIMUM AMOUNT .AVAILABI.I PIA FISCAL YEAR: FY 14: $193,008.00 CON I'ItNCI OR RI IPRI SI N I A I IVE: Mark Wallace Weld County Department of Public Health and Environment 1555 North 17111 Avenue Greeley, Colorado 80631 Contractor shall provide services for the Colorado Family Planning Initiative (CFPI) and the Family Planning Program (FPP). Page 1 of 6 Rev 6/25/09 EXHIBITS- 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. 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(l), 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, §24-103.5-101 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 §24-103.5-101, 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: Board of County Commissioners 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 Legal Name of Contracting Entity % Signatre t' Authorzed O ffice William F. Garcia For Executive Director Department of Public Health and Environment MAY 0 6 2013 Print Name of Authorized Officer Chair, Board of Weld County Commissioners Print Tide of Authorized Officer STATE OF COLORADO: John W. Hickenlooper, GOVERNOR 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 Date ge-%t'`r/ .13 Page 5 of 6 Rev 6/25/09 074/3-1/f This page left intentionally blank. Page 6 of 6 Rev 6/25/09 EXHIBIT A ADDITIONAL PROVISIONS To Task Order Contract Dated 04/23/2013 - Contract Routing Number 13 FLA 55556 These provisions are to be read and interpreted in conjunction with the provisions of the Task Order Contract specified above. 1. The list of acronyms attached hereto as Attachment A-1 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 state, private, and federal funds (see Catalog of Federal Domestic Assistance (CFDA) number 93.217). 3. The United States Department of Health and Human Services ("USHHS"), through the United States Public Health Service ("USPHS") has awarded federal funds under Award number FPHPA086074-01-00, hereinafter "Award", to perform the following — provide comprehensive reproductive health care in Colorado, with a primary focus on contraceptives. If the underlying Award authorizes the State to pay all allowable and allocable expenses of a contractor as of the effective date of that Award, then the State shall reimburse the Contractor for any allowable and allocable expenses of the Contractor that have been incurred by the Contractor since the proposed effective date of this Task Order Contract. If the underlying Award does not authorize the State to pay all allowable and allocable expenses of a contractor as of the effective date of that Award, then the State shall only reimburse the Contractor for those allowable and allocable expenses of the Contractor that are incurred by the Contractor on or after the effective date of this Task Order Contract, with such effective date being the later of the date specified in this Task Order Contract or the date the Task Order Contract is signed by the State Controller or delegee. 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. To receive compensation under this Task Order Contract, the Contractor shall submit a signed monthly CDPHE Reimbursement Invoice Form. This form is accessible from the CDPHE interact website http://www.colorado.gov/cs/Satellite/CDPHE-Main/CBON/125 1622941228 and is incorporated herein by reference. CDPI-IE will provide technical assistance in accessing and completing the form. The CDPHE Reimbursement Invoice Form 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 the Statement of Work attached hereto as Exhibit B and incorporated herein and the associated Budget attached hereto as Exhibit C and incorporated herein. All completed CDPHE Reimbursement Invoice Forms and signature sheets should be PDF'd into one document. Email completed forms to: cdphe.pswomenshealth@state.co.us 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 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 no later than sixty (60) calendar days from the effective expiration or termination date of this Task Order Contract. To be attached to CDPHE Task Order v1.0 (3/12) contract template Page 1 of 4 - Revised: 12/19/06 EXHIBIT A The Contractor shall not use federal funds to satisfy federal cost sharing and matching requirements unless approved in writing by the appropriate federal agency. Sliding Fee Scale: The Contractor's charges for services to clients who are above 100% of poverty level shall be based on a sliding fee scale that takes into account a client's family size and/or individual income and is approved by the State. These charges and the sliding fee scale shall be made available to all clients of the Contractor, the general public, and the State. This document is incorporated and made part of this SOW by reference and is available on the following website: http://www.colorado.gov/cs/Satellite/CDPHE-PSD/CBON/1251618366665 under fiscal forms. The content of electronic documents located on CDPHE and non-CDPHE websites and information contained on CDPHE and non-CDPHE websites may be updated periodically during the contract term. CDPHE will notify the contractor of all updates. The Contractor shall comply with all updates. Charges shall be based upon the Contractor's actual costs to provide these services as determined by a cost analysis. The Contractor and the State shall review these costs annually. The Contractor shall insure that all clients understand that they will not be denied services because of an inability to pay any of the Contractor's sliding fee charges. Fiscal and Spending Contract Award: It is important that accurate expenses are reflected in each contract budget. The Contractor must spend the entire awarded and budgeted amount for services identified in the annual approved project budget. Failure to provide projected services, submit invoices in a timely manner, and/or failure to spend the award at a rate that results in the full award being expended at the end of the program year may result in reduced funds the following year and/or lack of eligibility for mid -year and other additional funding opportunities. 6. 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. 7. 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. 8. 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 twenty-five percent (25%) of the total budget. Contractor shall submit a Budget Revision Request Form to request prior approval for all budget modifications in excess of twenty-five percent (25%) of the total budget. The Budget Revision Request Form is incorporated herein by reference and is located at http://www.colorado.aov/cs/Satellite/CDPHE- To be attached to CDPHE Task Order v1.0 (3/12) contract template Page 2 of 4 Revised: 12/19/06 EXHIBIT A PSD/CBON/125 1618366665 under Fiscal Forms tab. Any request for modification to the Budget in excess of twenty-five percent (25%) of the total budget or $250,000.00, whichever is less, shall be submitted to the State at least 90 days prior to the end of the contract period and may require an amendment in accordance with Section 5 of this Task Order Contract. 9. Contractor shall only use program income generated from client fee collections and donations for family planning purposes that further the objectives of the legislation under which this Task Order Contract is entered into. In accordance with Title X guidelines, the Contractor shall not charge for any Title X required services provided to clients who are at or below 100% of the official poverty line as defined by the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. 9902(2). If the State receives new poverty guidelines during the term of this Task Order Contract, then the State will immediately notify the Contractor. The Contractor shall use these new poverty guidelines, if any, upon receipt of notification thereof from the State. 10. All money received by the Contractor from the State under this Task Order Contract shall be used by the Contractor to provide contraceptive services to qualified family planning clients. 11. The State may require forms attached to this Task Order Contract and incorporated herein to be updated by the Contractor during the term of this Task Order Contract. The State shall notify the Contractor of newly developed forms. Forms are incorporated herein by reference and located on http://www.colorado.gov/cs/Satellite/CDPHE-PSD/CBON/1251618366665 under Administrative Forms tab. 12. 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. 13. 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. To be attached to CDPHE Task Order v1.0 (3/12) contract template Page 3 of 4 Revised: 12/19/06 EXHIBIT A 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 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. Contractor agrees to provide services to all Program participants and employees in a smoke -free environment in accordance with Public Law 103-227, also known as "the Pro -Children Act of 1994", (Act). Public Law 103-227 requires that smoking not be permitted in any portion of any indoor facility owned or leased or contracted for by an entity and used routinely or regularly for the provision of health, day care, early childhood development services, education or library services to children under the age of 18, if the services are funded by Federal programs either directly or through State or local governments, by Federal grant, contract, loan, or loan guarantee. The law also applies to children's services that are provided in indoor facilities that are constructed, operated, or maintained with such Federal funds. The law does not apply to children's services provided in private residences; portions of facilities used for inpatient drug or alcohol treatment; service providers whose sole source of applicable Federal funds is Medicare or Medicaid; or facilities where Women, Infants and Children (WIC) coupons are redeemed. Failure to comply with the provision of Public Law 103-227 may result in the imposition of a civil monetary penalty of up to $1,000 for each violation and/or the imposition of an administrative compliance order on the responsible entity. By signing this Task Order Contract, Contractor certifies that Contractor shall comply with the requirements of the Act and shall not allow smoking within any portion of any indoor facility used for the provision of services for children as defined by the Act. Contractor agrees that it shall require the language of the Act be included in any subcontracts which contain provisions for children's services and that all subcontractors shall sign and agree accordingly. 16. Notwithstanding the terms contained in the General Provisions of the Master Contract, Section 10, Confidential or Proprietary Information, the Contractor shall protect the confidentiality of all applicant or recipient records and other materials that are maintained in accordance with this Task Order Contract. Except for purposes directly connected with the administration of this Task Order Contract, no information about or obtained from any applicant or recipient shall be disclosed in a form identifiable with the applicant or recipient without the prior written consent of the applicant or recipient, or the parent or legal guardian of a minor applicant or recipient with the exception of information protected by Colorado Statute as it applies to confidentiality for adolescent services in which case the adolescent minor and not the parent or legal guardian must provide consent or as otherwise properly ordered by a court of competent jurisdiction. Contractor shall have written policies governing access, duplication, and dissemination of all such information. Contractor shall advise its employees, agents, servants, and any subcontractors that they are subject to these confidentiality requirements. 17. The State may increase or decrease funds available under this Task Order Contract using a Grant Funding Letter substantially equivalent to Attachment A-2. The Grant Funding Change Letter is not valid until it has been approved by the State Controller or designee. To be attached to CDPHE Task Order v1.0 (3/12) contract template Page 4 of 4 Revised: 12/19/06 Attachment A-1 Commonly Used Acronyms and Abbreviations That May Be Referenced In the Scope of Work: ACS American Cancer Society ACNS Alamosa County Nursing Service ACE Administration for Children and Families ADA Americans with Disabilities Act ADAD Alcohol and Drug Abuse Division AHA 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 for Non -Smokers' Rights ARC Addiction Recovery Centers ARRA American Recovery and Reinvestment Act ASC Adams State College ASSIST American Stop Smoking Intervention Study ASTIIO Association of State and Territorial Health Office B&G Boys & Girls BACCHUS BACCHUS Peer Education Network BAG Build a Generation BBLHC Boulder Broomfield Latino Health Coalition BC Boulder County BCCP Breast and Cervical Cancer Program BCHD Bent County Health 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 BUIS Broomfield High School BMTF' Baby & Me Tobacco Free BOCES Board of Cooperative Educational Services BOH Board of I lealth 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 CASE 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 Larimer 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 1of6 Attachment A-1 CCFCI 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 CJD 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 CPHA Colorado Public Health Association CPT Current Procedural Technology CRC Colorectal Cancer 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 University 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 Health (CDC) DCMH Delta County Memorial Hospital DH Denver Health DIIIIA Denver Health and Hospital Authority DES Department of Human Services DHFIS Unites States Department of I lealth and Human Services DOR Department of Revenue DOS Delta Opportunity School DSS Department of Social Services E&l Education and Information EAP 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 Larimer County Page 2 of 6 Attachment A -I ECLC Early Childhood Leadership Council/Commission E.D. Executive Director EHR Electronic Health Record 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 (aka_ secondhand smoke) FIRC Family and Intercultural Resource Center FICA The Federal Insurance Contribution Act FDA Food and Drug Administration FCUFOBT Fecal Immunochemical Test/Fecal Occult Blood Test FNA Final Needle Aspiration FPP Family Planning Program FPL Federal Poverty Level FRCC Front Range Community College FTE Full Time Equivalent FTP 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) GLBT Gay, Lesbian, Bisexual, and Transgender GYN Gynecological HCP Health Care Program For Children with Special Needs HCYS Huerfano County Youth Services NHS Health and Human 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 HRSA Health Resources and Services Administration HSI, High School Leadership ID Identification IIK Invest in Kids ESHT Interagency School Health Team IT Information Technology JAC Juvenile Assessment Center KIS Keeping in STEPP KMH Keefe Memorial Hospital KPC Kevin Patrick Calcum LAHCDHD Las Animas Huerfano Counties District I lealth Department LBW Low Birth Weight LC Learning Community LGBT Lesbian, Gay, Bisexual, Transgender LEM Latins en Movimiento L.HA Local Health Agency LHD Local Health Department LLC Limited Liability Company LRCC Latino Regional Community Coalition LRPC Latino a Research and Policy Center Page 3 of 6 Attachment A-1 LST Life Skills Training LSTPEN Latino Statewide Tobacco Prevention and Education Netw LWB Live Well Broomfield MCHA Montezuma Housing Authority MCHD Montezuma County I lealth Department MCHS 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 MOU Memorandum of Understanding MPA Master of Public Administration in Health and Human Services MPH Master of Public Health MRI Magnetic Resonance Imaging Scan MS Master of Science MSA Master Settlement Agreement MUH 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 NASBE National Association of State Board of Education NCCRT National Colorectal Cancer Round Table NCHD Northeast Colorado Ilealth Department NCI National Cancer Institute NE North East NFP Nurse -Family Partnership NFPNSO Nurse -Family Partnership National Service Office NHVP Nurse Home Visitor Program NIDA National Institute on Drug Abuse NIH National Institute of Health NJH National Jewish Medical and Research Center N -O -T Not -on -Tobacco, (AI .A's Youth Smoking Cessation Program) NP Nurse Practitioner NPP Nurturing Parenting Program NRT Nicotine Replacement Therapy NSBA National School Boards Association OSH Office on Smoking or Health (CDC) OTC Over the Counter PA Physician's Assistant PAC Prevention Awareness Crew PACT Partners Assessing Chew Tobacco PAT Parents as Teachers PCCHD Pueblo City -County Health Department PPC Personal Care Providers PE Presumptive Eligibility PEN Parent Engagement Network PVCHC 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 Page 4 of 6 Attachment A-1 PO Purchase Order PPC Policy Partner Committee PPFC Pikes Peak Family Connections PPN Prevention Policy Network 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 Q I Quarter One Q2 Quarter Two Q3 Quarter Three Q4 Quarter Four QI Quality Improvement QOL Quality of Life RDAC Regional Disparities Advisory Council RFA Request for Applications RFP Request For Proposals RIE Reach. Implementation and Effectiveness RII IEL Regional Institute for I lealth and Environment RMC Rocky Mountain Center for Health Promotion & Education RMRH Rocky Mountain Rural Health RMYC Rocky Mountain Youth Corps RN Registered Nurse Rx Prescription RY Reconnecting Youth SafeCare SAMHSA Substance Abuse Mental Health Services Administration SB School -based System SBAG Salida Build A Generation SBHC School -Based Health Centers SCYC School Community Youth Coalition SCRHC Southern Colorado Regional flealth Collaborative SD Service Delivery SECH Southeast Colorado Hospital SEMHS 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 SHS Secondhand Smoke SIDS Sudden Infant Death Syndrome SLV San Luis Valley SMART Staying Motivated at Reducing Temptations SMART OUTCOME OBJECTIVE Specific, Measurable, Achievable, Realistic. Time -Round SMSU Self Management Service Unit SRO School Resource Officer STD Sexually Transmitted Disease STEPP State Tobacco Education and Prevention Partnership STW 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 Page 5 of 6 Attachment A -I TAG Technical Advisory Group (for evaluation & TPEG 1 TANF Temporary Aid to Needy Families TARP Tobacco Advocacy and Resource Partnership TBD To Be Determine TCP Tobacco Control Partners TDAC Tobacco Disparities Advisory Council TDG Tobacco Disparities Grant TDS Tobacco Disparities Subcommittee .[EACH Teaching Equity to Advance Community Health TEFAP The Emergency Food Assistance Program TEPCGP Tobacco Education Prevention and Cessation Grant Program TEPP Tobacco Education Prevention Partnership TFCCI Tobacco -Free Colorado Communities Initiative TFLC Tobacco Free Latimer County TFS Tobacco -Free Schools TFS I.aw Tobacco -Free Schools Law TGYS Tony Grampsas Youth Services Title V Tide 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 TTI Tony Grampsas Tobacco Initiative UCD University of Colorado — Denver UCDHSC Health Sciences Center at tJCD (sometimes abr. UCHSC) UCDHSC University of Colorado at Denver and Health Sciences Center URI. Uniform Resource Locator US United States of America USSTC US Smokeless Tobacco Company VP Vice President Well COA Wellness Councils of America WHIZ Women's Health Unit WIC Women, Infants, Children WWC Women's Wellness Connection Y4r,.C Youth at Crossroads YE Youth Empowerment YPI I 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 GRANT FUNDING CHANGE LETTER Date: State Fiscal Year: Grant Funding Change Letter # CMS Routing # TO: Insert Grantee's name In accordance with Section of the Original Contract routing number , [insert the following language here if previous amendment(s), renewal(s) have been processed] as amended by [include all previous amendment(s), renewal(s) and their routing numbers], [insert the following word here if previous amendment(s), renewal(s) have been processed] between the State of Colorado, Department of Public Health and Environment and Contractor's Name beginning Insert start date <insert start date of original contract> and ending on Insert ending date <insert ending date of current contract amendment>, the undersigned commits the following funds to the Grant: The amount of grant funds available and specified in Section of <insert contract amendment number and routing number> is ❑ increased or ❑ decreased by $amount of change to a new total funds available of $ <insert new cumulative total> for the following reason: . Section is hereby modified accordingly. This Grant Funding Change Letter does not constitute an order for services under this Grant. The effective date of hereof is upon approval of the State Controller or , whichever is later. STATE OF COLORADO John W. Hickenlooper, GOVERNOR Department of Public Health and Environment PROGRAM APPROVAL: BY: By: Lisa Ellis, Purchasing & Contracts Unit Director Date: ALL GRANTS REQUIRE APPROVAL BY THE STATE CONTROLLER CRS §24-30-202 requires the State Controller to approve all State Grants. This Grant is not valid until signed and dated below by the State Controller or delegate. Grantee is not authorized to begin performance until such time. If Grantee begins performing prior thereto, the State of Colorado is not obligated to pay Grantee for such performance or for any goods and/or services provided hereunder. STATE CONTROLLER David J. McDermott, CPA By: Date: Page 1 of 1 Effective Date: 1/6/09 -Rev 8/25/09 EXHIBIT B STATEMENT OF WORK To Task Order Dated 04/23/2013 - Contract Routing Number 13 FLA 55556 These provisions are to be read and interpreted in conjunction with the provisions of the Task Order Contract specified above. L Project Description: The goal of the Colorado Family Planning Initiative (CFPI) and The Colorado Department of Public Health Family Planning Program (FPP) is to reduce unintended pregnancy by insuring access to quality reproductive health services to all Coloradoans. Services include but are not limited to contraceptive, preventative health counseling and education services, reproductive health related testing and screening and referrals. Contractor shall conduct a comprehensive family planning program, herein referred to as "the program". The program shall comply with section 1001 of the federal Act and all applicable federal regulations, as amended, contained in Title X, 42 C.F.R., Subpart A, Part 59, as well as all applicable state regulations. (Federal funding from HITS, CFDA #93.217 FP Services). Funding is based on the number of clients served. The goal for the number of clients served annually is outlined in the associated Budget attached hereto as Exhibit C and incorporated herein. Project Term: June 30, 2013 -June 30, 2014 ►I. Performance Requirements/Deliverables: I. The Contractor shall: a. Provide comprehensive family planning services to sustain the total number of qualifying family planning clients served in the previous calendar year (fertile clients receiving contraceptive services). b. Provide outreach services and/or other program efforts designed to improve client recruitment; c. Supply nursing and medical services, which shall include a comprehensive health and social history and physical examination administered in accordance with all applicable Title X regulations and, all applicable nursing -medical policies or procedures which have been, or may be established by the State, specifically the Health Service and Connections Branch ; d. Supply contraceptive information, education, and supplies regarding all family planning methods; e. Provide education and counseling services regarding family planning, family planning methods, child spacing, infertility, sterilization, nutrition, sexually transmitted diseases, HIV/AIDS, adolescent counseling and other related health issues, as outlined in the Nursing and Administrative Manual; f Follow-up and/or provide referral services, as appropriate. g Purchase long acting reversible methods of contraception. These are limited to Intrauterine Devices (IUD) Mirena and Paraguard, and contraceptive implants. h. Provide the referral process and cover the actual costs of tubal ligation and vasectomy procedures. i. Notwithstanding the foregoing, under no circumstances shall private funding be used to purchase any pills, patches, Depo-Provera injections, condoms, or emergency contraceptive. Page I of 3 Exhibit B -Statement of Work V 1/MAR2012 EXHIBIT B 2. Guidelines and Manuals: The services provided by the Contractor to the clients it serves shall be performed pursuant to law in accordance with prevailing medical standard of care for the same or similar medical, nursing and professional services. The services provided shall also comply with applicable CFPI, Title X regulations, CDPHE FPP nursing -medical policies and procedures, and any applicable fiscal or administrative policies of the State or Federal government. This document is incorporated and made part of this SOW by reference and is available on the following website: http:/!www.colorado.gov/cs/Satellite/CDPIIE-PSD/CBON/1251618366665. The content of electronic documents located on CDPHE and non-CDPHE websites and information contained on CDPHE and non-CDPHE websites may be updated periodically during the contract term. CDPHE will notify the contractor of all updates. The Contractor shall comply with all updates. Contractor acknowledges having reviewed and accepted these policies and procedures. 3. The services provided by the Contractor must be deemed acceptable and in good faith by the State. For a service to be "acceptable" it must comply with all applicable: CFPI requirements, Title X regulations, CDPHE FPP nursing -medical policies and procedures, and any applicable fiscal and administrative policies and procedures of the State and Federal government. All applicable Title X regulations, CDPHE FPP nursing -medical policies and procedures, and all applicable fiscal or administrative policies of the State have been provided to the Contractor by the State as of the effective date of this Task Order Contract. 4. Data Submission: On a monthly basis, Contractor shall collect and provide to the State, by the fifteenth calendar day of the following month unless otherwise specified by the State, all pertinent data as defined by the State regarding all services offered, and all family planning clients served, by its program during the preceding month, submitted through the Family Planning data system. This document is incorporated and made part of this SOW by reference and is available on the following website: http://www.colorado.gov/cs/Satellite/CDPHE- PSD/CBON/ 1251618366665 under Title X Administrative Manual section. Contractor also agrees to respond to other data requests required by the program. 5. Reporting: a. Within thirty (30) calendar days of receipt of a written request from the State, the Contractor shall submit nursing -medical chart audits, client satisfaction surveys, Full Time Equivalent (FIE) reports and other documentation required for the Family Planning Annual Report (FPAR) to the State. b. Expenditure Revenue Reports: Contractor shall provide the State with the semi-annual Family Planning Expenditure/Revenue Reports. The first report is for the months of July through December (due January 31 annually); the second report is for the months of January through June (due July 30 annually). The Expenditure/Revenue Report form is incorporated and made part of this SOW by reference and is available on the following website: http://www.colorado.gov/cs/Satellite/CDPI IE- PSDCBON/1251618366665 under Fiscal Forms section. c. Progress Report: Contractor shall participate in state -level evaluation efforts as requested by the State including, but not limited to, progress reports on the implementation and accomplishments of the approved Work Plan in a format provided by the State. Progress reports shall be due in January 31 annually (for activity July -December) and July 30 annually (for activity January -June). Failure to submit acceptable reports by the due date may result in a delay or denial of the reimbursement request. 6. Laboratory: Contractor shall either use a cytology laboratory chosen by the State or, a laboratory proposed by the Contractor and approved by the State. 7. Referral: Contractor shall refer families participating in any and all programs in its agency such as the Special Supplemental Program for Women, Infants and Children (WIC), Early and Periodic Screening, Diagnosis and Treatment (EPSDT), Immunization Clinics, Health Care Program for Children with Special Health Care Needs (HCP), Prenatal Plus (PNP), etc. to appropriate enabling and direct care service programs in the community. Contractor shall provide all pregnant women in need of resources for prenatal medical care information about Page 2 of 3 Exhibit B -Statement of Work V 1/MAR2012 EXHIBIT B programs such as WIC, PNP, etc. as needed and shall ensure that children ages birth through two years who may be eligible for early intervention services are referred to Early Intervention Colorado. 8. Meetings: Contractor shall participate in meetings or trainings as requested by the State. 9. Staffing: Contractor shall require any new family planning coordinator or fiscal staff working on Family Planning Program services to participate in Program and Fiscal Orientation within forty-five (45) days of employment. III. Personnel: Contractor shall follow personnel requirements as specified in most recent CDPHE FPP nursing and administrative manuals. Professional health care providers must be in compliance with State and Federal licensing requirements and regulations. This document is incorporated and made part of this SOW by reference and is available on the following website: http://www.colorado.gov/cs/Satellite/CDPHE-PSD/CBON/1251618366665 Data Coordinator: Contractor shall identify a Primary Data Coordinator who shall annually submit to the State a list of Family Planning data system users. Contractor shall notify the State within thirty (30) days of a change of the Primary Data Coordinator. 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. IV. Monitoring CDPHE's monitoring of this contract for compliance with performance requirements will be conducted throughout the contract period by the FPP Unit Manager. Methods used will include review of documentation reflective of performance including progress reports and other documentation as applicable. The Contractor's performance will be evaluated at set intervals and communicated to the contractor. A Final Contractor Performance Evaluation will be conducted at the end of the life of the contract. VI. Resolution of Non -Compliance The Contractor will be notified in writing within 30 calendar days of discovery of a compliance issue. Within 45 calendar days of discovery, the Contractor and the State will collaborate, when appropriate, to determine the action(s) necessary to rectify the compliance issue and determine when the action(s) must be completed. The action(s) and time line for completion will be documented in writing and agreed to by both parties. If extenuating circumstances arise that requires an extension to the time line, the Contractor must email a request to the family planning unit manager and receive approval for a new due date. The State will oversee the completion/implementation of the action(s) to ensure time lines are met and the issue(s) is resolved. If the Contractor demonstrates inaction or disregard for the agreed upon compliance resolution plan, the State may exercise its rights under the Remedies section of the General Provisions of this contract. Page 3 of 3 Exhibit B -Statement of Work V 1/MAR2012 Exhibit C Colorado Department of Public Health and Environment PREVENTION SERVICES DIVISION- BUDGET WITH JUSTIFICATION FORM Contract Routing # 13 FLA 55556 Colorado Department of Public Health and Environment Contractor Name Weld County Department of Public Health and Environment Budget Period lune 30, 2013 -tune 30, 2014 Project Name Title X Family Planning and CFPI Budget Program Contact Name, Title, Phone and Email Kimberly Koeltzow, Clinical Services Manager, 970-304-6420 ext 2337, kkoeltzow@colweld.co.us Fiscal Contact Name, Title, Phone and Email Tanya Geiser, Administrative Services Director, 970-304-6410 ext 2122, tgeiser@co.weld.co.us Number of Target Clients (19 -years and younger, 150% FPL or below) to be served in 2013-2014:2015 Expenditure Categories Match or In - Kind (If Applicable) Total Amount Requested from CDPHE Personal Services Gross or Annual Salary Fringe Percent of FTE on Project Position Title/Employee Name Description of Work (for hourly employees, please include the hourly rate and number of hours in your description). Include P of months budgeted. List SOW objective/activity number(s) this budget item supports L Dunn Clinical Nurse Practitioner (12 months) $ 87,850 $ 34,200 100.00% $122,049 A Odell Clinical Nurse Practitioner (12 months) $ 87,850 $ 34,200 80.00% 47,330 $50,310 38.93% fringe includes: 1.45% medicare, .09% unemployment, .08% workers comp, - 13.7% PERA, 12.13% health & disability insurance, .33% life insurance, 11.14% paid time off - Total Personal Services (including fringe benefits) $ 175,699 $ 68,400 1.80 47,330 172,359 Supplies & Operating Expenses Item Description of Item List SOW objective/activi ty number(s) this budget item supports Rate Quantity Match or In kind (if applicable) Total Amount Requested from CDPHE Total Supplies & Operating Expenses - - Travel Page 1 of 3 Exhibit C Colorado Department of Public Health and Environmeo, Colorado Department of Public Health and Environment PREVENTION SERVICES DIVISION- BUDGET WITH JUSTIFICATION FORM Contract Routing # 13 FLA 55556 Contractor Name Weld County Department of Public Health and Environment Budget Period June 30, 2013 -June 30, 2014 Project Name Title X Family Planning and CFPI Budget Program Contact Name, Title, Phone and Email Kimberly Koeltzow, Clinical Services Manager, 970-304-6420 ext 2337, kkoeltzow@colweld.co.us Fiscal Contact Name, Title, Phone and Email Tanya Geiser, Administrative Services Director, 970-304-6410 ext 2122, tgeiser@co.weld.co.us Number of Target Clients (19 -years and younger, 150% FPL or below) to be served In 2013-2014: 2O15 Rem Description of Item List SOW objective/activi ty number(s) this budget item supports Rate Quantity Match or In kind (if applicable) Total Amount Requested from CDPHE Total Travel Contractual (payments to third parties or entities) Item Subcontractor Entity Name and/or Description of Item. List SOW objective/activi ty number(s) this budget item supports Rate Quantity Match or In kind (if applicable) Total Amount Requested from CDPHE Total Contractual SUB -TOTAL BEFORE INDIRECT 172,359 Page 2 of 3 Exhibit C Colorado Department of Public Health and Environment PREVENTION SERVICES DIVISION- BUDGET WITH JUSTIFICATION FORM Contract Routing # 13 FLA 55556 Colorado Department of Public Health and Environment Contractor Name Weld County Department of Public Health and Environment Budget Period lune 30, 2013 -June 30, 2014 Project Name Title X Family Planning and CFPI Budget Program Contact Name, Title, Phone and Email Kimberly Koeltzow, Clinical Services Manager, 970-304-6420 ext 2337, kkoeltzow@colweld.co.us Fiscal Contact Name, Title, Phone and Email Tanya Geiser, Administrative Services Director, 970-304-6410 ext 2122, tgeiser@co.weld.co.us Number of Target Clients (19 -years and younger,150% FPl or below)to be served in 2013-2014:2015 Indirect Item Description of Item (description is not necessary for the negotiated rate agreement) Match or In kind (if applicable) Total Amount Requested from CDPHE Negotiated Indirect cost rate (Federal or CDPHE) CDPHE-11.98% FY13 5,670 20,649 Indirect (other): please list specific indirect costs in description if no rate exists Indirect (other): Modified budget item rate, if applicable Total Indirect 5,670 20,649 TOTAL MATCH OR IN KIND 53,000 TOTAL 193,008 Page 3 of 3 Good morning Weld County Commissioners. Thank you for giving me this opportunity to address you concerning the reactivation of Plan B The Emergency Contraception Pill in our Weld County Clinics. Because you have a 3 -minute rule for presentations we are dividing this presentation into two parts. I will take the first 3 minutes and Rochelle Galindo will finish the last 3 minutes. My name is: Sharon Voightmann My address is: 1430 41' Avenue, Greeley, Weld County Commissioner District 2. I have worked and paid taxes in Greeley for 36 years. My name is Rochelle Galindo My address is 2725 W 15th Street, Greeley, Weld County Commissioner District 1. When I attended the March 6, 2013 meeting and Plan B The Emergency Contraception Pill was addressed by the community -at -large, Commissioner Garcia was asked why he voted to keep Plan B The Emergency Contraception Pill pill from being dispensed in the Weld County Clinics and one of his responses was that he felt that it was fiscally sound to stop because Weld County was experiencing an economic recession and this was in the interest of a good allocation of County funds. I would like to address that decision by giving the Commissioners some facts and figures to show why that was not a good fiscal decision. According to The National Campaign to Prevent Teen and Unplanned Pregnancy, July 2012, "in 2011 roughly one-third of all high school students reported being sexually active — that is, they had sex in the previous three months. Rates of sexual activity were similar among girls (34% and boys (33%). Of these 6% reported they first had sex before age 13 and 15% reported having already had four or more sexual partners with boys (18%) being higher than girls (13%)." And from the April -May 2011 National Conference of State Legislatures Legisbrief, "The bad news is that U.S. teen pregnancy, birth and abortion rates are the highest in the developed world." Now let's bring it home to Weld County. According to the State of Colorado Public Health and Environmental Health Statistics for Weld County, 2011 saw a total of 3,731 births, of which 886 were born to unmarried women. Of these, four were to teens age 13- 14. This was up from 2010 which had three and 2009 which had 1 or 2 (the department doesn't show a count if the number is 2 or less). Also the statistics showed 90 births to teenagers 15-17 and an interesting total showed up of 95 for all teenagers 10-17, which says to me that a little girl either age 10, 11 or 12 gave birth sometime in 2011 in Weld County. Sharon Voightmann Page 1 5/3/13 That brings us to cost. Again quoting from The National Campaign to Prevent Teen and Unplanned Pregnancy, July 2012, "Most of the public sector costs of teen childbearing are associated with negative consequences for the children of teen mothers, during their childhood and their young adult years. In Colorado in 2008, taxpayer costs associated with children born to teen mothers included $22 million for public health care (Medicaid and CHIP); $49 million for child welfare; and, for children who have reached adolescence or young adulthood $36 million for increased rates of incarceration and $47 million in lost tax revenue due to decreased earnings and spending. (Note that while this breakdown reflects costs associated with the children of teen mothers the total cost figure reflects costs for both the children and their parents. Also note that because we cannot measure and include all out comes and all costs, the analysis should be considered conservative, that is, it is likely that the full costs of a teen birth are greater than the figures presented here." According to The 2012 Health Status Report and Community Health Improvement Plan, A Roadmap for Improving Weld County's Health we had in" 2010 252, 825 residents of which 14% lived in poverty and 11% of children and 22% of adults (18-64) were uninsured." The same report stated the following facts: According to the fall 2010 Weld Health Kids Colorado Survey, 8 percent of teenagers reported being physically forced to have sexual intercourse when they did not want to. Alsto the 2012 report stated that the percentage of pregnancies (among women aged 15+ years) resulting in live births that were unintended from 2007-2009 was 37% of total pregnancies, and the rate of live births to teen mothers (21.8) in Weld County is higher than the statewide rate (17.4 per 1,000." Using the United State's Department of Agriculture (USDA) Center for Nutrition Policy and Promotion Expense Calculator we can calculate the cost of one child born in Weld County. This is based on an overall annual estimated cost to a one parent with income less than $59, 410. The total this group came up with was a yearly expense $10,010 for one child. (This figure included housing, food, transportation, clothing, health (costs not covered by insurance, including insurance premiums), child care and education, and miscellaneous expenses. Since the percentage is about 25% that a teenager will become pregnant more than once, I also used this same expense calculator to figure what two children would begin costing annually and this figure came to $16, 112. Let us now return to the year 2011 that saw at least 94+ births to teenagers aged 10-17. According to our USDA calculator that was an expense of $940,940 to raise those children to age 18. Sharon Voightmann Page 2 5/3/13 Since we know from the statistics of 2007-2009 37% of total pregnancies were unintended, let us again be conservative and say that in 2011 only 35% were unintended. That would give us approximately 107 unintended live births at a cost of $108,070. Bringing us to Plan B The Emergency Contraception Pill. From what I can determine this choice of prevention cannot cost Weld County as much as what Walmart, Walgreen's, or King Soopers charge their customers. Their costs range from $40 - $60 for Plan B The Emergency Contraception Pill. Planned Parenthood charges $38 and Latimer County Health Clinic was charging their clientele zero to $10. So even if Plan B The Emergency Contraception Pill cost Weld County $30 a dose (and because of the 340B program that allows purchase of pharmaceuticals at a discounted rate, I don't think Weld County pays that much).Weld County would only have paid out a total of $3,210 to prevent these unplanned pregnancies. Comparing the 107 unintended live births yearly cost of $108,070, adding up to $1,945,260 plus by age 18, to a one time cost of $3,210 seems tthe more fiscally responsible choice for our Weld County Commissioners to make when overseeing the budget expenses for the citizens of Weld County. The cost of teen childbearing in 2008 cost the taxpayers of Colorado $161 million dollars. It is a fiscally responsible decision to offer the relatively inexpensive choice of Plan B The Emergency Contraception Pill to help prevent the costs of unintended pregnancies. Thank you for your time and attention. Sharon Voightmann Page 3 5/3/13 Portal About Final Report News Room Meetings & Activities trios Mark Wallace, MD, MPH Guiding Principles Contact Us Commissioner Bios Erik Arun idown Elisabeth Arenales, Esq. Clarke Becker Carrie A. Besnette Ph.D. Christy Blakely Peg Burnette Dave Downs, MD, FACP Steve ErkenBrack Lisa Esgar Linda Gorman Julia Greene Allan Jensen Grant Jones Donald Kortz William N. Lindsay Ill CLU, CEBS, RPA Donna Marshall, MBA Pam Nicholson Ralph Pollock, MPH David Rivera Arnold Salazar Mark Simon Dan Stenersen Steven Summer Mark Wallace, MD, MPH Mark Wallace, MD, MPH Get Help Search Proposals +w i Evaluation Innovating at a local level, Dr. Mark Wallace, acting with two other healthcare leaders, founded and continues to serve as President of the North Colorado Health Alliance. The Alliance is a non-profit organization dedicated to expanding access by the un- and underinsured to affordable health care, improving the quality of care delivered to these populations, and eliminating disparities in health outcomes between the insured and uninsured. Since 2000 he has served as the Executive Director of the Weld County Department of Public Health & Environment. From 1994 until his appointment by the Board of County Commissioners as Executive Director, Dr. Wallace served as the Medical Advisor to the Countyts health department. He serves as the vice-president of both the Weld County Medical Society Board of Directors and the Colorado Academy of Family Physicians Board of Directors. Dr. Wallace is also the Chairman of the Board of Directors of Sunrise Community Health Center. As a board certified Family Physician since 1987 he continues to see patients every week. He attended the Keck School of Medicine at the University of Southern California receiving his medical degree in 1984. Dr. Wallace subsequently completed a 3 -year residency in Family Practice at the UCLA -Santa Monica Hospital Medical Center and then a 1 -year post -graduate fellowship in Academic Family Medicine at the UCLA Center for the Health Sciences. He received his Masters in Public Health from the UCLA School of Public Health in 1989. Dr. Wallace completed the Johnson & Johnson/UCLA Health Care Executive Program at the John E. Anderson Graduate School of Management at UCLA in 2004. Dr. Wallace received the 2005 Community Health Care Champion Award from the Colorado Community Health Network, a 2005 Colorado Association of School Boardts McGuffy Award for educational leadership, the 2005 Sarah Jane Gilliland Distinguished Service Award by the Colorado Association of School Boards, a 2003 Angel Award from the Weld County Medical Society, the 2002 Joan Weber Lynn Westberg, RN Barbara Yondorf Conflict of Inleresl Staff Fiscal Sponsor FAQs Colorado Medical Society Physician Award for Community Service, and the 2000 UNC Sigma Theta Tau (Zeta Omicron Chapter) International Honor Society of Nursing Community Leadership Award. He gives generously of his time outside of work to serve the community including elected office having served 8 years, six as President, on the Weld County School District 6 Board of Education. Dr. Wallace is married to Beverly. Together they have two daughters, Tessa (20) who attends CU -Boulder, and Tara (17) who is a senior at Greeley West High School. 515/13 Catholic journal says Plan B does not cause abortions j National Catholic Reporter HOME I ABOUT I ADVERTISE I CONTACT I GIVING TO NCR THE INDEPENDENT NEWS SOURCE ACCOUNTABILITY ART & MEDIA FAITH & PARISH GLOBAL PEACE &JUSTICE POLITICS ICS SPIRITUALITY THEOLOGY VATICAN SISTERS' STORIES CathoLic journal says Plan B does not cause abortions by NCR Staff ! Mar. 31, 2010 48 Plan B, the nation's most widely used emergency contraceptive, works only as a contraceptive and does not cause abortions, according to an article in the official journal of the Catholic Health Association. (La Opinion/j. Emilip Flores) WASHINGTON -- If it holds, a finding in a Catholic health journal could be the key to ending a major dilemma for Catholic health facilities across the nation and around the world. Plan B, the nation's most widely used emergency contraceptive, works only as a contraceptive and does not cause abortions, according to an article in the January -February issue of Health Progress, the official journal of the Catholic Health Association. Theologian Lisa Sowle Cahill of Boston College said if Plan B never causes abortions, then ncronline.org/news/catholic-journal-says-plan-b-does-not-cause-abortions 119 5/5/13 Catholic journal says Plan B does not cause abortions l National Catholic Reporter Catholic hospitals should have no moral problem providing it as an emergency contraceptive to a rape victim. Under the U.S. bishops' "Ethical and Religious Directives for Catholic Health Care Services," Catholic facilities may administer emergency contraception to a rape victim, but only to prevent ovulation or fertilization. Ethical and Religious Directive 36 says if the procedure causes an already fertilized egg to be destroyed or prevents its implantation in the womb, in Catholic teaching that is no longer contraception but abortion. The difference between the Catholic definition of abortion (any destruction of a fertilized human egg) and the American Medical Association's definition (any destruction of an embryo following its implantation -- typically about seven days after fertilization) is a major subtext in the debate over whether Plan B is only contraceptive or also possibly abortifacient in some cases. Read all the NCR content that isn't available on our website. Subscribe now. Barr Pharmaceuticals, manufacturer of Plan B, follows the medical association's definition in describing the drug as strictly contraceptive and suggests that one effect could be to prevent implantation of a fertilized egg, a conclusion challenged by several scientific studies. Dr. Sandra E. Reznik, who teaches reproductive endocrinology and reproductive pharmacology at St. John's University in New York, wrote in Health Progress that Plan B is widely regarded in the scientific community as "the most effective emergency contraceptive agent available." Plan B is Barr's brand name in the United States and several other countries for the contraceptive drug levonorgestrel. Commenting on the thesis of the article, Capuchin Franciscan Fr. Thomas Weinandy, executive director of the U.S. bishops' Secretariat for Doctrine and Pastoral Practices, said, "If it can be proved, that would make a difference" as to how Catholic hospitals, doctors and pharmacists treat Plan B. The distinction between preventing fertilization and preventing implantation is a crucial moral point in Catholic teaching on the difference between contraception and abortion, but in the American Medical Association's definition of contraception, both are treated equally. In a phone interview, Cahill said Reznik's conclusions matched those she has seen in other literature on the topic, including an article in the Oct. 11, 2006, issue of The Journal of the American Medical Association, which she had just recently read in preparing to teach a bioethics course. She said she knew of at least two states -- Massachusetts since 2005 and Connecticut since 2007 -- that have laws requiring hospitals to provide Plan B emergency contraception to ncrordine.org/rtms/catholic-journal-says-plan-b-does-not-cause-abortions 2/9 5/5/13 Catholic journal says Plan B does not cause abortions I National Catholic Reporter rape victims. A number of other states -- California, Illinois, New Jersey, New Mexico, New York and Washington among them -- require hospitals to offer rape victims emergency contraception or at least inform them where to obtain it. The question of whether Plan B can also prevent implantation of a fertilized egg as well as prevent ovulation and inhibit sperm from reaching the egg led the Catholic bishops and four Catholic hospitals of Connecticut to oppose that state's 2007 legislation on emergency contraception unless it allowed hospitals to test for pregnancy and ovulation before administering the drug. In its final form, the law permitted hospitals to do a pregnancy test before administering Plan B, but not an ovulation test. The question of what tests could be performed before emergency contraceptive treatment is important because of the time -sensitive nature of Plan B. As Reznik put it, "The effectiveness of Plan B decreases with every passing hour, because the chance of missing [the pill's prevention of] ovulation increases as time passes -- and science has demonstrated Plan B doesn't work after ovulation occurs." In a carefully worded statement Sept. 27, 2007, shortly after the Connecticut law was enacted, the state's bishops and Catholic hospital leaders said they "believe that this law is seriously flawed, but not sufficiently to bar compliance with it at the present time." They said they would continue to work to change the law, but they had come to a judgment that "to administer Plan B pills in Catholic hospitals to victims of rape, a pregnancy test to determine that the woman has not conceived is sufficient. An ovulation test will not be required. The administration of Plan B pills in this instance cannot be judged to be the commission of an abortion because of such doubt about how Plan B pills and similar drugs work and because of the current impossibility of knowing from the ovulation test whether a new life is present. To administer the Plan B pills without an ovulation test is not an intrinsically evil act." "The teaching authority of the church has not definitively resolved this matter," they added, and "if it becomes clear that Plan B pills would lead to an early chemical abortion in some instances, this matter would have to be reopened." The statement illustrates the delicacy and fine moral distinctions involved in trying to determine what Plan B actually does and the moral evaluations that would follow from a Catholic perspective. Reznik wrote that since it takes about a week from an egg's fertilization to its implantation, the scientific evidence that Plan B treatment is completely ineffective after five days is overwhelming: It works only by preventing fertilization, not by preventing implantation. ncronline.org/netis/catholic-journal-says-plan-b-does-not-cause-abortions 3/9 5/5/13 Catholic journal says Plan B does not cause abortions ( National Catholic Reporter Otherwise, she said, the drug would also be found effective from five to 12 days after coitus, because that is the time frame between the last chance for a sperm to fertilize an egg and the time a fertilized egg would implant. The declining effectiveness of Plan 13 between 48 and 120 hours after coitus adds to the argument that preventing a fertilized egg from being implanted is not one of its effects, she said. Cahill told NCR that if scientific data show conclusively that Plan B is only contraceptive, any pregnancy or ovulation test before its use as an emergency contraceptive after rape "seems to me an unjustified delay that increases the possibility that the raped woman will become pregnant." "From the evidence that you were just telling me [from the Health Progress article] and that I read in The Journal of the American Medical Association, it has a limited effectiveness -- you have to use it right away," she said. Plan B apparently "does not affect pregnancies that are already established, so what's really the point in doing a pregnancy test?" she asked. "It doesn't seem to have a scientific validity to it in the way that Plan B, by all accounts, operates." "If the Catholic church wants to put its abortion teaching, its pro -life teaching, in the best light possible, it really has to be accompanied by equally dedicated and aggressive attempts to help women," she said. "Taking measures to prevent medically appropriate and legally mandated assistance to basics in the name of protecting the unborn -- in ways that are indicated scientifically not protecting the unborn anyway -- that just seems to undermine the pro -life stance of the Catholic church. "So I think politically it's a really bad idea even in terms of the church's own goals," she added. "And practically, it's a huge injustice to the women who have been raped." print email Like' 3171 TweetV 181 48 IS/CR Comment code: ® Be respectful. Do not attack the writer. Take on the idea, not the messenger. a Don't use obscene, profane or vulgar language. • Stay on point. Comments that stray from the original idea maybe deleted. We are not able to monitor every comment that comes through. If you see something objectionable, please click the "Report abuse" button. Once a comment has been flagged, an NCR staff member will investigate. 5/5113 Catholic journal says Plan B does not cause abortions I National Catholic Reporter For more detailed guidelines, visit our User Guidelines page. For help on how to post a comment, visit our reference page. 5 comments Leave a message... ®eat - Community marabouescorts • 22 days ago nice blog, very interesting! http://maraboulondonescorts.co... • Reply Share > londonladies • 22 days ago nice content, thx http://londonladiesinred.com/ v4: " Reply Share > bambooescorts • 22 days ago great blog, thanks you http://bamboolondonescorts.com... 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Have the bishops found their 'attractive, articulate. intelliaent' spokeswoman? 5/9 516/13 Catholic Journal says Plan B does not cause abortions i National Catholic Reporter _ _ _ _ _ _ . _ _ •.7 _ _ _ _ _ •_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 682 corrarants • 11 days ago rsY; Purgatrix lneptfae —'Radical feminist" is kind of like "disgruntled postal worker." You will never find a postal worker who calls himself Comment feed Ei Subscribe via email 1 SEAR NCR EMAIL ALERTS 216 comments • 6 days ago CAELewis — "...will become the first spokeswoman for the president of the U.S. Conference of Catholic Bishops, the USCCB Sign up to get NCR updates by email. Existing users: change your preferences here. Enter your email address in the box below and click "Go." Privacy by 2r SafeSutiscribes" ncronline orginewskatholiciournel-says-plan-t►does-rat-cause-abortions 619 Alvs 5/5/13 Morning -Alter Pill: Pitttildbritrotersyftlainaill.M0ealthNevesDAtcom .; LOnlo1/4kt_- The History and Future of Birth Control `° iYr�i it,st in '�li Morning -After Pill: Plan B Controversy Explained Dec 8, 2011 1 1:12 PM ET I Rachael Refiner, MyHealthhNewsDaily Staff Writer Recommend r36I Twsot'8 0 Share Now that the U.S. Department of Health and Human Services has said it will continue to require adolescents 17 years of age and younger to obtain prescriptions before taking the emergency -contraceptive pill Plan B (also known as the morning -after pill), we answer some questions you might have about the decision. How does Plan B work? Plan B, manufactured by Teva Women's Health, contains levonorgestrel, a hormone found in most birth control pills, but a a higher dose. Plan B should be taken within 72 hours of unprotected sex and is intended to prevent pregnancy if other forms of contraception fall or if no contraception was used, according to Teva. 1 Tip To Lose Belly Fat .. ractecar;.is;ac. rr:"oa-a.::.or:n Cut pounds of stomach fat every week by using this 1 weird old tip. 2013 Best Skin Tighteners itiww.ukriCareSearch.co aceLil np An Unbiased Review List of The Top Performing Skin Tighteners In 2013 Why men Fall In Love i 1?.;he :,a,io,„ irwou,<<ra:,f:.'aorn 9 Powerful Words You Can Say That Remind Him Why He Needs You. Ads by Google Plan B mainly prevents pregnancy by lease of an egg from the ovary and by preventing the fertilization of at eg, said Dr. Christopher Estes, assistant professor of obstetrics and gynecology at the University o of M divine. While a uterus, it does not interfere with the implantation of a fertilized egg, Este: said. In fact, in order to stabilize the pregnancies of women who've previously suffered miscarriages, doctors give a drug very similar to plan Is it the same as the abortion pill? No. Plan B is a contraception pill, meaning it prevents pregnancy. Ifyou are already rye tgt__ant, the pill will not work. The drug "will not disrupt or affect an existing pregnancy," according to Teva. www.nOealihnewsdaily can11994morning-pill-planr-coldroversyelolained.htnil 21s 5/5/13 Morning -After Pill: Plan !3 ContrmersyEplained ( MyHealthNewsDailycom The "abortion pill," or mifepristone, can terminate pregnancy, and can be taken up until a woman is 9 weeks pregnant, according to Planned Parenthood. Why did HIS say teens need a prescription for it? Plan B is currently available over the counter (without a prescription) for women ages 17 and older. Women younger than 17 can get the drug, but they need a prescription. Teva submitted an application to the FDA seeking to have Plan B approved for over-the-counter use in all women able tc bear children. In order to receive approval, the company needed studies showing the drug is safe and effective in adolescent women, and that young women would understand how to use the drug appropriately without consulting a doctor. HHS Secretary Kathleen Sebelius said the studies submitted to the FDA did not meet this requirement because they "did not contain data for all ages for which this product would be available for use." Although girls in early adolescence are capable of having children, there are significant cognitive and behavioral differences between the youngest and oldest adolescents, Sebelius said. She noted that about 10 percent of girls begin menstruation when they are around 11 years ok What is the FDA's stance? The Center for Drug Evaluation and Research, part ofthe FDA, said it reviewed Teva's application and determined Plan I was safe and effective for use in girls younger than 17, and that these young women understood how to use the product appropriately. Dr. Margaret Hamburg, FDA commissioner, said, '1 agree with the Center that there is adequate and reasonable, well - supported and science -based evidence that Plan B One -Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential." However, the HHS did not agree with the FDA's decision and overruled it. What do doctors say? The decision by HSS was a 'political move that's trumping actual evidence based medicine," Estes said. Estes noted: 'There are drugs available over the counter for anyone who wants to buy them, that are more dangerous thar Plan B. For example, "it's easy to overdose on Tylenol (acetaminophen) because of the number ofpills included in one package, he said. "You can really hurt yourselfwith a bottle of Tylenol with a couple of dollars, Estes said. But It's almost impossible to overdose on Plan B," he said, because of the large number ofpills you would need to take t achieve a toxic dose. Three medical organizations, the American Academy of Pediatrics (AAP), the American Congress of Obstetricians and Gynecology (The College) and the Society of Adolescent Health and Medicine (SAHM), have denounced the decision b: HHS to keep Plan B available to adolescents by prescription only. The AAP says the decision goes against the current evidence supporting the use of emergency contraception in adolescent women. 'The decision to continue restricting access to this safe and effective product is medically inexplicable," Dr. Robert Block, president of the AAP, said in a statement issued yesterday (Dec. 7). The AAP and SAHM still recommend that adolescents be counseled on use of emergency contraception by their doctor, but say such counseling can occur in the context of a larger discussion about safe sex and family planning. wmv myhealthnewsdaily com11994-morning-pill-plan-controversy-eplai ned.html 3/8 5/5/13 Morning -After Pill: Plan B ControtiersyE,plained j My4ealthNewsDailycom How much does it cost? The cost of Plan B can range between $35 and $60, according to Estes. What are the side effects and risk? Plan B can cause changes in a woman's menstrual cycle,nausea, lower -abdominal pain, fatigue, headache, dizziness and breast tenderness, according to Teva. Follow MyHealthNewsDaily staff writer Rachael Rettner on Twitter @RachaelRettner. Find us on Facebook. -- 'Recommend V 361 r --ti Tweet] 0 Share • 11 Big Fat Pregnancy Myths • Catholic Church Should Offer Nuns the Pill. Researchers Say • The History and Future of Birth Control SPONSORED FROM AROUND THE WEB How Cruise Ships Fill Their Unsold Cabins Why Shampoos How to Speed Are a Waste of Up Your PC - Money Tricks Manufacturers New Natural Testosterone Booster Has Men Raving How Penny Stocks Create Millionaires Every Day [Add a concert... L Post to Facebook Posting as Patricia Gifford (Not you?) Would you lke to T� subscribe to our weekly newsletters? Comment Jeanne Brady • Eastern High School Girls 17 and younger would need a prescription to go to a pharmacy alone and purchase emergency contraception, or a parent or other trusted adult can purchase the pills OTC for them. Reply • Like • Follow Post • December 9, 2011 at 1:07am Andrea Eskew • Follow • Grunt at A -Z Lock huh... they say here that it's 17, but in Arizona, you have to show ID and be at least 18. Reply • Like • Follow Post - December 8, 2011 at 10:00pm Jeanne Brady • Eastern High School 17 and younger would need a prescription. Over 17 (18 and up) would not. Reply • Like • December 9, 2011 at 1:09am Facebook social plugin wwernyhealttinewsdaily.coml1984-f oning-pill-plan-cont ersy-nlain8d.htni 4/8 5/5/13 Morning -After Pill: Plan 8 ControrersyE lained MyNealthNev Daily.com urgent response - • Seniors Face Deadly Risk From Common Drugs ® Arthritis Sufferers Find Hope in Joint Oil 9 Dr. Hibberd: Does Yogurt Really Help Your Digestive System? a Easy Weight Loss; Allan, 55, Loses Inches of Belly Fat ® Do You Support the NRA on Gun Rights? Vote in Urgent Poll O Seven Steps to Prevent Deadly Blood Clots o Emergency Radio Essential to Emergency Preparedness a Alzheimer's Reversed? New Study Gives Hope What's This? MOST POPULAR ARTICLES top Al cats That Can Make You Sick 19,450 views vwwtmyhealihnemdaily.com/1994-morning-pill-plan-contro ersy-eplained.htni 5/8 International Consortium for Emergency Contraception. Hosted by Family Care International 588 Broadway, Suite 503 New York, NY 10012 Phone: +1 212 941 5300 International Federation of Gynecology & Obstetrics (FIGO) Suite 3 - Waterloo Court 10 Theed Street London SE1 8ST Phone: +44 20 7928 1166 www.emergencycontraception.org • www.figo.org International Federation of Gynecology & Obstetrics (FIGO) March 2012 International Consortium for Emergency Contraception MECHANISM OF ACTION How do levonorgestrel-only emergency contraceptive pills (LNG EGPs) prevent pregnancy'? Levonorgestrel-only emergency contraceptive pills: • Interfere with the process of ovulation; • May possibly prevent the sperm and the egg from meeting. The evidence shows that LNG ECPs: Impair ovulation: • A number of studies provide strong direct evidence that LNG ECPs prevent or delay ovulation. If taken before ovulation, LNG ECPs inhibit the pre-ovulatory luteinizing hormone (LH) surge, impeding follicular development and maturation and/or the release of the egg itseif.1'2,3,4,5.6.7•9 This is the primary mechanism of action for LNG ECPs. Do not inhibit implantation: • Two studies have estimated effectiveness of LNG ECPs by confirming the cycle day by hormonal analysis (other studies used women's self -reported cycle date). In these studies, no pregnancies occurred in the women who took ECPs before ovulation; while pregnancies occurred only in women who took ECPs on or after the day of ovulation, providing evidence that ECPs were unable to prevent implantation.a10 • A number of studies have evaluated whether ECPs produce changes in the histological and bio- chemical characteristics of the endometrium. Most studies show that LNG ECPs have no such effect on the endometrium, indicating that they have no mechanism to prevent implantation.',2,"•12,13 one of these studies found that following administration of double the standard dose of LNG, there are only minor or no alterations in endometrial receptivity.12 One study found a single altered endometrial param- eter only when LNG was administered prior to the LH surge, at a time when ECPs inhibit ovulation.14 • One study showed that levonorgestrel did not prevent the attachment of human embryos to a simulated (in vitro) endometrial environment.15 • Animal studies demonstrated that LNG ECPs did not prevent implantation of the fertilized egg in the endometrium.i6'17 May affect sperm: • Contradictory results exist regarding whether LNG taken post-coitally and in doses used for EC affects sperm function. • Early studies suggested that LNG ECPs interfere with sperm motility by thickening cervical mucus.18,19 However, two in vitro studies found that LNG in doses used for EC has no direct effect on sperm function.2O'29 Recent in vivo studies found no effect of LNG on the number of viable sperm found in the female genital tract 24-28 hours after taking LNG.22 Interference in sperm migration is also a possible explanation in women who took LNG ECP before ovulation, but had documented follicle rupture in the following 5 days, yet did not get pregnant.9 • New evidence about the interaction between sperm and progesterone suggests a possible deleterious effect of high concentrations of the progestin LNG on sperm function, that may cause sperm to hyperactive in the absence of an egg or interfere with directionality of the sperm movement.23,24 • Given these results, this mechanism of action is still uncertain and warrants further studies. Do not have an effect on pregnancy: • Two studies of women who became pregnant in cycles when they took LNG ECPs found no difference between pregnancy outcomes of women who had taken LNG ECPs and those who had not. Variables included miscarriage, birth weight, malformations, and sex ratio, indicating that LNG ECPs have no effect on an established pregnancy even at very early stages 23,24 Other facts: • Emergency contraception is not the same as early medical abortion. LNG ECPs are effective only in the first few days following intercourse before the ovum is released from the ovary and before the sperm fertilizes the ovum. Medical abortion is an option for women in the early stage of an established preg- nancy, but requires a different drug from levonorgestrel. • LNG ECPs cannot interrupt an established pregnancy or harm a developing embryo. Implications of the research: • Inhibition or delay of ovulation is LNG ECPs principal and possibly only mechanism of action. • Review of the evidence suggests that LNG ECPs cannot prevent implantation of a fertilized egg. Language on implantation should not be included in LNG ECP product labeling. • The fact that LNG ECPs have no demonstrated effect on implantation explains why they are not 100% effective in preventing pregnancy, and are less effective the later they are taken. Women should be given a clear message that LNG ECPs are more effective the sooner they are taken. • LNG ECPs do not interrupt a pregnancy (by any definition of the beginning of pregnancy). However, LNG ECPs can prevent abortions by reducing unwanted pregnancies. International Consortium for Emergency Contraception ICEC is hosted by Family Care International 588 Broadway • Suite 503 • New York, NY • 10012 • USA www.emergencycontraception.org • www.figo.org References ' Marions L, Hultenby K, Lindell I, Sun X, Stabi B, Gemzell-Danielsson K. Emergency contraception with mifepristone and levonorgestrel: mechanism of action. Obstetrics and Gynecology 2002; 100(1): 65-71. 2 Durand M, del Carmen Cravioto M, Raymond EG, Duran -Sanchez O, De la Luz Cruz-Hinojosa M, Caste Rodriguez A, Schiavon R, Larrea F. On the mechanisms of action of short-term levonorgestrel administration in emergency contraception. Contraception 2001; 64(4): 227-234. 3 Hapangama D, Glasier AF, Baird DT. The effects of pert-ovulatory administration of levonorgestrel on the menstrual cycle. Contraception 2001; 63(3): 123-129. 4 Marions L, Cekan SZ, Bygdeman M. Gemzell- Danielsson K. Effect of emergency contraception with levonorgestrel or mifepristone on ovarian function, Contraception 2004; 69(5): 373-377. 5 Croxatto HB, Brache V, Pavez M, Cochon L, Forcelledo ML, Alvarez F, Massai R, Faundes A, Salvatierra AM. Pituitary -ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75 mg dose given on the days preceding ovulation. Contraception 2004; 70(6): 442-450. 6 Okewole IA, Arowojolu AO, Odusoga OL, Oloyede OA, Adeleye OA, Salu J, Dada OA. Effect of single adminis- tration of levonorgestrel on the menstrual cycle. Contraception 2007; 75(5): 372-377. ' Croxatto HB, Devoto L, Durand M, Ezcurra E, Larrea F, Nagle C, Ortiz ME, Vantman D, Vega M, von Herizen H. Mechanism of action of hormonal preparations used for emergency contraception: a review of the literature. Contraception 2001; 63(3): 111-121. 3 Massai MR, Forcelledo ML, Brache V, Tejada AS, Salvatierra AM, Reyes MV, Alvarez F, Faundes A, Croxatto HB. Does meloxicam increase the incidence of anovulation induced by single administration of levonorgestrel in emergency contraception? A pilot study. Human Reproduction 2007; 22: 434-9. ° Noe G, Croxatto H, Salvatierra AM, Reyes V, Villarroel G, Munoz C, Morales G, Retamales A. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception 2011; 84 486-492. 10 Novikova N, Weisberg E, Stanczyk FZ, Croxatto HB, Fraser IS. Effectiveness of levonorgestrel emergency contraception given before or after ovulation - a pilot study. Contraception 2007; 75(2): 112-118. "Meng CX, Andersson K, Bentin-Ley U, Gemzell- Danielsson K, Lalitkumar PG. Effect of levonorgestrel and mifepristone on endometrial receptivity markers in a three-dimensional human endometrial cell culture model. Fertility and Sterility 2009; 91(1): 256-64. 12 Meng CX, Marions L, Bystrom B, Gemzell-Danielsson K. Effects of oral and vaginal administration of levonorg- estrel emergency contraception on markers of endo- metrial receptivity. Human Reproduction 2010; 25(4): 874-883. 13 Palomino W, Kohen P, Devoto L. A single midcycle dose of levonorgestrel similar to emergency contraceptive does not alter the expression of the L-selectin ligand or molecular markers of endometrial receptivity. Fertility and Sterility 2010; 94(5): 1589-1594. 14 Durand M, Seppala M, Cravioto M del C, Koistinen H, Koistinen R, Gonzalez-Macedo J, Larrea F. Late follicu- lar phase administration of levonorgestrel as an emer- gency contraceptive changes the secretory pattern of glycodelin in serum and endometrium during the luteal phase of the menstrual cycle. Contraception 2005; 71(6): 451-457. 75 Lalitkumar PG, Lalitkumar S, Meng CX, Stavreus-Evers A,Hambiliki F, Bentin-Ley U, Gemzell-Danielsson K. Mifepristone, but not levonorgestrel, inhibits human blastocyst attachment to an in vitro endometrial three- dimensional cell culture model. Human Reproduction 2007; 22(11): 3031-3037. 16 Muller AL, Llados CM, Croxatto HR. Postcoital treat- ment with levonorgestrel does not disrupt postfertilization events in the rat. Contraception 2003; 67(5): 415-419. 17 Ortiz ME, Ortiz RE, Fuentes A, Parraguez VH, Croxatto HB. Post -coital administration of levonorgestrel does not interfere with post -fertilization events in the new world monkey Cebus apella. Human Reproduction 2004; 19(6): 1352-1356. 16 Kesseru E, Camacho-Ortega P, Laudahn G, Schopflin G. In vitro action of progestogens on sperm migra- tion in human cervical mucus. Fertility and Sterility 1975; 26(1): 57-61. 19 Kesseru E, Garmendia F, Westphal N, Parade J. The hormonal and peripheral effects of d-norgestrel in post - coital contraception. Contraception 1974; 10(4): 411-24. 2° Brito KS, Bahamondes L, Nascimento JA, de Santis L, Munuce MJ. The in vitro effect of emergency contra- ception doses of levonorgestrel on the acrosome reaction of human spermatozoa. Contraception 2005; 72(3): 225-8. 21 Yeung WS, Chiu PC, Wang CH, Yao YQ, Ho PC. The effects of levonorgestrel on various sperm functions. Contraception 2002; 66(6): 453-7. 22 Do Nascimento JA, Seppalla M, Perdigao A, Espejo- Arce X, Munuce MJ, Hautala L, Koistinen R, Andrade L, Bahamondes L. In vivo assessment of the human sperm acrosome reaction and the expression of glycodeling-A in human endometrium after levonorgestrel-emergency contraceptive pill administration. Human Reproduction 2007; 22(8): 2190-5. 23 Hoft WV and Fazeli A. The oviduct as a complex mediator of mammalian sperm function and selection. Molecular Reproduction & Development 2010; 77: 934-43. 24 Kolle S, Reese, Kummer W. New aspects of gamete transport, fertilization , and embryonic development in the oviduct gained by means of live cell imaging. Thermiogenology 2010; 73: 786-95. .25 Strunker T, Goodwin N, Brenker C, Kashikar ND, Weyand I, Seifert R, Kaupp UB. The CatSper channel mediates progesterone -induced Ca2+ influx in human sperm. Nature 2011; 471: 382-6. 2° Lishko PV, Botchkina IL, Kirichok Y. Progesterone activates the principal Ca2+ channel of human sperm. Nature 2011; 471: 387-91. 27 Teves ME, Guidobaldi HA, Unates DR, Sanchez R, Miska W, Publicover SJ, Morales Garcia M, Giojalas LO. Molecu- lar mechanism for human sperm chemotaxi mediated by progesterone. PlosOne 2009; 4 (12): e8211; 1-11. 2° Zhang L, Chen J, Wang Y, Fangming R, Yu W, Cheng L. Pregnancy outcome after levonorgestrel-only emer- gency contraception failure: a prospective cohort study. Human Reproduction 2009; 24(7): 1605-1611. 29 De Santis M, Cavaliere AF, Straface G, Carducci F, Caruso A. Failure of the emergency contraceptive levonorgestrel and the risk of adverse effects in preg- nancy and on fetal development: an observational cohort study, Fertility and Sterility 2005; 84(2): 296-299. www.emergencycontraception.org • www.figo.org Plan One -Step (levonorgestrel) tablet, 1.5 mg Contact: Heather Rose Communications Strategies, Inc. 973-635-6669 Denise Bradley Teva Pharmaceuticals 215-591-8974 Plan B® One -Step Emergency Contraception a New Option for U.S. Women Trusted Product Now Available in a One -Pill, One -Step Formulation What Plan Be One -Step Is: • Newly FDA -approved Plan B® One -Step (levonorgestrel tablet, 1.5 mg) is an innovative one -pill emergency contraceptive that can help prevent an unintended pregnancy in just one dose after unprotected sex or contraceptive failure • The sooner Plan Be One -Step is taken, the more effective it will be. When taken as directed, within 72 hours (3 days) of unprotected sex or contraceptive failure, Plan B® One -Step is highly effective in reducing the chance of pregnancy. About seven out of eight women who would have gotten pregnant will not become pregnant after taking it. • Plan B® One -Step consists of one oral tablet containing 1.5 mg of the progestin levonorgestrel, an ingredient found in many oral contraceptives • Plan Be One -Step works primarily by preventing ovulation or fertilization What Plan Be One -Step Isn't; • Plan Be One -Step is not the "abortion pill" (RU -486 or mifepristone) • Plan B® One -Step is not effective if a woman is already pregnant, and it will not terminate an existing pregnancy • Plan Be One -Step is not a substitute for routine contraception and should not be used that way because it is not as effective How to Obtain Plan Be One -Step? • Plan Be One -Step is available over-the-counter (OTC) at the pharmacy without a prescription for consumers (men and women) age 17 or older. To purchase, consumers must show a valid government -issued proof -of -age identification; a prescription is required for women younger than age 17 • Plan Be One -Step is sold from behind the pharmacy counter and is offered in the same packaging, regardless of whether it is dispensed OTC or by prescription • Nine U.S. states have pharmacy -access policies that allow women of any age to obtain Plan Be One -Step from participating pharmacists at select pharmacies without a prescription: Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont, and Washington -more- Facts About Plan B® One-Step/2 Is Plan B® One -Step Safe?: • When used as directed, Plan B® One -Step (levonorgestrel tablet, 1.5 mg) is safe for most women. The most common side effects associated with the use of Plan B® One -Step include changes in one's period, nausea, lower abdominal pain, fatigue, headache, dizziness, and breast tenderness • Women may experience menstrual changes (changes in your period) after taking Plan B® One -Step. In some cases, their next period may be heavier or lighter, earlier or later. it is important to consult a healthcare professional if one's scheduled period is more than one week late, as pregnancy may have occurred Important Information: • There is no evidence that Plan B® One -Step harms a pregnant woman or a developing fetus • Plan B® One -Step, like all oral contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases About Teva Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe. Important Safety Information PLAN B® ONE-STEP IS INTENDED TO PREVENT PREGNANCY Alei'ER KNOWN OR SUSPECTED CONTRACEPTIVE FAILURE OR UNPROTECTED INTERCOURSE. Plan B® One -Step isn't effective if you're already pregnant, and it won't terminate an existing pregnancy. Plan B® One -Step doesn't protect against HIV and other sexually transmitted diseases (STDs). Side effects may include changes in your period, nausea, lower abdominal pain, fatigue, headache, dizziness, and breast tenderness. If your period is more than a week late, you may be pregnant. If you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical help. Please see full product information enclosed. Important safety information is also available on www.PlanBOneStep.com, by calling 1-800-330-1271, or by speaking to your pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA at fda.gov/medwatch or call 1 -800 -FDA -1088. Plan B® One -Step is a registered trademark of Women's Capital Corporation, a subsidiary of Duramed Pharmaceuticals, Inc. ## 5/5/13 Science at Issue in Debate on Morning -After Pill - NYTimes.com Subscribe: Digital I Home Delivery ' Log In 'Register Now Help - JOME PAO4+ TODAY'S PAPER I VIDEO I MOST POPULAR ] U.S. Edition llje Xetbpork gimcs Research Search Ali NYTimes.com C2 tit�1 uune WORLD ( U.S. (N.Y. / REGION ',BUSINESS TECHNOLOGY i SCIENCE i HEALTH LSPORTS OPINION ARTS ; STYLE I TRAVEL j JOSS i REAL ESTATE AUTOS Search Health 3,000+Topics j Inside Health I ) Research 1 Fitness & Nutrition ; Money & Polley ; Views ! Health Guide llcjetlt4erkems Home del very ± FREE ALL IIIOIIAL ACCESS POLITICAL SCIENCE Abortion Qualms on Morning -After Pill May Be Unfounded By PAM BELLUCK Published: June 5, 2012 540 Comments __.-1 Labels inside every box of morning -after pills, drugs widely used to FACEBOOK prevent pregnancy after sex, say they may work by blocking fertilized T ATITER eggs from implanting in a woman's uterus. Respected medical authorities, including the National Institutes of Health and the Mayo Clinichave said the same thing on their Web sites. Enlarge This Inge Pelricke WalVlhe New York Times Political Science When a Label Sticks Articles in this series explore the intersection of politics and science. Revlous Articles in the Series s Related Drug's Nickname May Have Aided Politicization (June 6, 2012) Such descriptions have become kindling in the fiery debate over abortion and contraception. Based on the belief that a fertilized egg is a person, some religious groups and conservative politicians say disrupting a fertilized egg's ability to attach to the uterus is abortion, "the moral equivalent of homicide," as Dr. Donna Harrison, who directs research for the American Association of Pro - life Obstetricians and Gynecologists, put it. Mitt Romney recently called emergency contraceptives "abortive r"na " And two former Republican presidential candidates, Gingrich and Rick Santorum, have made similar statements. z GOGGLE+ E-MAIL SHARE PRINT REPRINTS THE >- ji s i ltArci Ii—AHL'. Advertin on NYTimescam i Log In to see what your friends are sharing Log In With Facebook on nythres.com. Privacy Pokey ( What's This? What's Popular Now Israel Bombs Syria as the U.S. Weighs Its Own Options In Lean Years After Boom, Spain's Graft Laid Bare Think Like a Doctor: An Unusual Headache Solved May 3, 2013 Overweight Patients, Overweight Doctors: Readers Weigh In May3,2013 Caffeine -Laced Foods Spur F.DA. Investigation May 3, 2013 Expanding Your Kitchen Literacy: Dukkah May 3, 2013 Ask Well: Long -Term Risk of Antidepressants May 3, 2013 Advertise on NYTimescom Benellei;T;;?:? MORE iN RESEARCH (1 OF 30 ARTICLES) Agencies Get Creative to Make Up for Federal Cuts Read More q�>t But an examination by The New York Times has found Religious Groups Equate Some Contraceptives With Abortion (February 17, 2012) Times Topic: Plan B (Contraceptive) Related in Opinion Editorial: How Morning After Pills Really Work (June 9, 2012) See what the candidates have said about emergency contraception: Mitt Romney (Starting at (that the federally approved labels and medical Web sites do • not reflect what the science shows. Studies gave not established that ewer envy contraceptive pills prevent fertilized eggs from implanting in the womb, leading scientists say. Rather, the pills delay ovulation, the release of eggs from ovaries that occurs before eggs are fertilized, an some pills also thicken cervical mucus so sperm have trouble swimmin , It turns out that the politically charged debate over morning -after pills and abortion, a divisive issue in this election year, is probably rooted in outdated or incorrect scientific guesses about how the pills work. Because they block creation of fertilized eggs, they would not meet abortion opponents' definition of abortion -inducing drugs. In contrast, RU -486, a medication prescribed for GOODBYE GLUCOSAMINE SEE WHY YOU'LL NEVER HAVE TO USE GLUCOSAMINE AGAIN_. CLICK HERE TO SEE HOW Health & Fitness Tools Hsr , BMI Calculator What's your score? a MOSTE-MAILED RECOMMENDED FOR YOU 1. EDITORIAL Putting Politics Ahead of Science 5/5/13 15:3o.) Rick San'arum (Starting at 9:40.) Newt Gingrich (Starting at 8:3o.) Enlarge This hrmge Part of a handout included with packages of one of the medication Ran 8. Readers' Comments Readers shared their thoughts on this article. Read All Corrrnents (540) a terminating pregnancies, destroys implanted embryos. The notion that morning -after pills prevent eggs from implanting stems from the Food and Drug Administration's decision during the drug -approval process to mention that possibility on the label — despite lack of scientific proof, scientists say, and objections by the manufacturer of Plan B, the pill on the market the longest. Leading scientists say studies since then provide strong evidence that Plan B does not prevent implantation, and no proof that a newer type of pill,,, does. Some abortion opponents saidthey remain unconvinced. After The Times asked about this issue, A.D.A.M., the firm that writes medical entries for the National Institutes of Health Web site, deleted passages suggest iia emergency contraceptives could disrupt implantation. The Times, which uses A.D.A.M.'s content on its health Web page, updated its silt. The medical editor in chief of the Web site for the Mayo Clinic, Dr. Roger W. Harms, said "we are champing at the bit" to revise the entry if the Food and Drug Administration changes labels or other agencies make official pronouncements. ' l`ThPap m poi, , I4',"e aro there toprevent or delay ovulation," said . Petra M. y, an obstetrician -gynecologist at Mayo. "They don't act after fertilization." The F.D.A. declined to discuss decisions about the effect on implantation or to say whether • it would consider revising labels. But Erica Jefferson, an F.D.A. spokeswoman, acknowledged: "The emerging data on Plan B suggest that it does not inhibit implantation. Less is known about Ea. However, some data suggest it also does not inhibit implantation." Scientists say the pills work up to five days after sex, primarily stalling an egg's release until sperm can no longer fertilize it. Although many people think sperm and egg unite immediately after sex, sperm need time to position themselves. Controversy over emergency contraception is figuring in the presidential race and debates over the Obama administration's health care law. Some abortion opponents and religious groups are fighting the law because it requires insurers, including those for employees of Roman Catholic institutions that oppose birth control, to cover contraceptives, including morning -after pills. While some object to contraception generally, others focus on birth control methods that they believe cause abortions. And some proponents of "personhood" initiatives, proposals being put forward in several states to define fertilized eggs as people, say the initiatives would bar the pills if they work after eggs are fertilized. Doctors also say some patients who are not active on abortion issues want to resolve ethical questions about whether the pilLs affect a fertilized egg. A Growing Market While scientific and political disputes over emergency contraception may persist even if labels change, both sides consider the wording on labels central because it summarizes scientific consensus and shapes what medical authorities say. "F.D.A. labeling is important to us, it's very important," said Jeanne Monahan, director of the Center for Human Dignity at the Family Research Council, a conservative group. Diana Blithe, a biochemist who oversees contraception research for the National Institutes of Health, the federal agency for medical research, said the possibility of an effect on implantation should not be cited on the labels. "As a scientist, I would definitely take it off of emergency contraception," she said. Science at Issue in Debate on Morning -After Pill - NYTimes.com 2. EDITORIAL Putting Politics Ahead of Science 3. MOTHERLODE Is There Emergency Contraception in Your Medicine Cabinet? 4. U.S. to Defend Age Limits on Morning - After Pill Sales 5. Texas Legislators Set to Restore Women's -Health Budgets 6. Egypt's Birthrate Rises as Population Control Policies Vanish 7. Obama Backs Birth Control Rule Change 8. Movie Listings for May 3 -May 9 9. CITY ROOM A Surprise in Court: A School Board, Thought to Be Obsolete, Still Exists to. DOWNLOAD David Benioff Log In to discover more articles based on what you've read. Log In Registee Now tMrat'sThis? I Don't Shoot . PP for Bl �' RYr 1.0 Ads by Googie Golden Age of Country TM 8 CDs of Countrys Most Influential Artists +2 CDs of Hard to Find Hits VWM.TirneLife. com'Gold enCountry what's this? wov.rifirnes.com/2012/06106/heal thfresearthlmorning -after-pi Ils-dont-bl ock-implantati on-sciensuggests.hhnl?page ente&all& r=0 2/6 5/5/13 Science at Issue in Debate on Morning -After Pill - NYTimes.com Ninety-nine percent of the emergency contraception market in the United States consists of Plan B'(approved in 1999 and now sold as Plan B One -Step) and its generic versions, Next Choice and levonorgestrel tablets. They are available without prescription for women ages 17 and older. The other pill, Ella, became available by prescription only in the United States in late 2010. Emergency contraceptive use has steadily increased, with about 12 million packages sold last year, according to IMS Health and the SymphonylRI Group, health information and market research companies. European medical authorities have not mentioned an effect on implantation on Ella's label, and after months of scrutiny, Ella was approved for sale in overwhelmingly Catholic Italy, where laws would have barred it if it could be considered to induce abortion, said Erin Gainer, chief executive of Ella's manufacturer, Paris -based HRA Pharma. Some abortion opponents said that while emergency contraceptives' primary function may be delaying ovulation, they doubted that scientists could exclude the possibility of implantation effects. "I would be relieved if it doesn't have this effect," said Richard Doerflinger, associate director of the Secretariat of Pro -Life Activities for the United States Conference of Catholic Bishops. "So far what I see is an unresolved debate and some studies on both sides," he said, adding that because of difficulties in ethically testing the drugs on women, "it's not only unresolved, but it may be unresolvable." Several scientists acknowledged that absolute proof may be elusive; in science, as James Trussell, a longtime emergency contraception researcher at Princeton, said, "You can never prove the negative." But he and others said the evidence from multiple studies was persuasive. A Labeling Dispute How did the statement about implantation end up on F.DA-approved labels? Beginning with the 1999 approval process, the maker of Plan B — Barr Pharmaceuticals, later acquired by Teva Pharmaceuticals — asked the F.D.A. in writing not to list an implantation effect on the label, said people familiar with the requests who asked for anonymity because such discussions are considered confidential. Anti -abortion activists were not yet publicly focusing on the issue. "There were other drugs that I remember causing controversy," said Dr. Jane E. Henney, the F.D.A. commissioner then. "This wasn't one." Back then, scientific research concentrated on whether Plan B's active ingredient, a synthetic progesterone, safely and effectively prevented pregnancy, not on how it worked, said Dr. Krishna Gemzell-Danielsson, an obstetrics and gynecology professor at the Karolinska Institute in Sweden, who participated in World Health Organization studies leading to F.DA. approval. The F.D.A.'s own description was speculative, saying Plan B "could theoretically prevent pregnancy by interfering with a number of physiological processes" followed by a long list, including ovulation and implantation. A New York Times review of hundreds of pages of approval process documents found no discussion of evidence supporting implantation effects. Ms. Jefferson of the F.D.A. said it was often difficult when a drug is approved, and even afterward, to pinpoint how it works. Citing confidentiality rules, she would not discuss why the agency declined the company's request to omit implantation. Experts say implantation was likely placed on the label partly because daily birth control pills, some of which contain Plan B's active ingredient, appear to alter the endometrium, the lining of the uterus into which fertilized eggs implant. Altering the endometrium has wwwnylimes.com12012106/061healUUresearch/morning-after-pills-done Mock-implantation-saence suggests.tttml?pagewante&all& r=0 3/6 515/13 Science at Issue in Debate on Morning -After Pill - NYTimes.com not been proven to interfere with implantation. But in any case, scientists say that unlike the accumulating doses of daily birth control pills, the one-shot dose in morning -after pills does not have time to affect the uterine lining. "It takes time for an endometrium to change, for its cells to divide," said Susan Wood, a biochemist who, shortly after Plan B's approval became the F.D.A.'s top women's health official and later resigned, frustrated with the delay in making the pill available without prescription. Implantation also likely wound up on the label because of what Dr. Gem zell-Danielsson called wishful thinking by some scientists, who thought that if it could also block implantation, it would be even better at preventing pregnancy. By 2002, studies produced evidence that Plan B did not interrupt implantation. Abortion opponents were also becoming more vocal about emergency contraception. In 2005-6, when the F.D.A. reviewed Plan B, making it available without prescription for ages 17 and over, some opponents said it was an abortion -inducing drug. Plan B's maker again asked that implantation be removed from the label. Addressing the issue in a 2005 memorandum, Dr. Steven Galson, director of the F.D.A.'s Center for Drug Evaluation and Research, wrote that studies "conclusively demonstrate" that Plan B's ability to block ovulation, is "responsible for most, if not all, instances in which emergency contraception prevents pregnancy." But he also said that studies at that time could not exclude the possibility the pills impeded implantation "in a small percentage of women." He declined a request to be interviewed. By 2007, scientific consensus was building that morning -after pills did not block implantation. In one study using fertilized eggs that would have been discarded from fertility clinics, Dr. Gemzell-Danielsson found that adding Plan B in a dish did not prevent them from attaching to cells that line the uterus. ti Later, in 2007, 2oogand 2010,_ researchers in Australia and Chile gave Plan B to women after wring with hormone tests which women had ovulated and which had not. None who took the drug before ovulation became pregnant, underscoring how Plan B delays ovulation. Women who had ovulated became pregnant at the same rate as if they has taken no drug at all. In those cases, there were no difficulties with implantation, said one of the researchers. Gabriela Noe, at the I nstituto Chileno de Medicina Reproductiva in Santiago. Dr. Blithe of the N.I.H., said, "No one can say that it works to inhibit implantation based on these data." j The Evidence Grows In 2009-10, during discussions about making Plan B available over the counter for all ages, the manufacturer, Teva Pharmaceuticals, again asked that implantation be deleted from the label. The F.D.A. again declined. Valerie Mulligan, Teva's senior director of regulatory affairs, declined to discuss conversations about Plan B, but said, "There is quite a lot of evidence now that it doesn't affect implantation." By this year, the International Federation of Gynecology and Obstetrics considered the research so strong that it issued a statement saying that pills with Plan B's active ingredient "do not inhibit implantation." Research on Ella, approved in 2010, is less extensive, but the F.D.A., Dr. Blithe, and others say evidence increasingly suggests it does not derail implantation, citing, among other things, several studies in which women became pregnant when taking Ella after ovulating. The studies, focused on Ella's effectiveness, were not de. igned to determine if it blocked implantation, but experts still consider them significant. Dr. Trussell of Princeton said that if morning -after pills worked after eggs were fertilized, they would prevent pregnancy better than they do. The pregnancy prevention rates are vw.wrn+times.com12012/06106Thealthiresearch/morning-after-pills-dont-blodFimplantatiorrsclence-sugg esis.Nmf7pagevtented=all& r=0 4/6 5/5/13 Science at Issue in Debate on Morning -After Pill - NYTimes.com probably lower than scientists and pill makers originally thought, he said — in some studies as low as 52 percent for Plan B and 62 percent for Ella. By contrast, scientists say, research suggests that the only other officially approved form of emergency contraception, the copper intrauterine device (also a daily birth control method), can work to prevent pregnancy after an egg has been fertilized. Despite the accumulating evidence, several abortion opponents said they remain unpersuaded. Dr. Harrison, director of research and public policy for the American Association of Pro -life Obstetricians and Gynecologists, said that the Plan B studies were led by "a good researcher," but that she would prefer a study with more women and more documentation of when in their cycles they took Plan B. She added that if the studies done so far are correct, Plan B's label should say it is ineffective after ovulation. With Ella, Dr. Harrison cited a document from the European Medicines Agency (similar to the F.D.A.) and animal studies that she said suggest the lining of the uterus could be altered. Dr. Blithe said that the European document did not demonstrate that effect, and that the animal results were not analogous to human experience, partly because the doses were higher. So far, in only one human study have researchers suggested that Ella's active ingredient might thin the lining in doses higher than the dose in an Ella pill. But Dr. Blithe said that study, conducted by researchers at her agency, the N.I.H., produced results too unclear or insignificant to show that effect. Most human studies suggest otherwise, she said. Dr. Harrison also cited similarities between Ella's active ingredient and RU -486. But Dr. Anita L. Nelson, a professor of obstetrics and gynecology at University of California, Los Angeles, said RU -486's ingredient is given in a dose up to 20 times higher than Ella's ingredient and is taken when women are up to seven weeks pregnant, long after the egg has implanted. Steps by government agencies or medical Web sites to revise language about implantation are already causing controversy. Recently, some abortion opponents criticized two agencies of the Department of Health and Human Services for online fact sheets that omit an implantation effect or say that science undermines it. A department spokesman explained the fact sheets, saying "the public should have access to the most accurate and up-to-date scientific information available on matters of preventative health, including contraception." Critics said they wondered if scientists and government agencies were debunking an implantation effect because they support abortion rights. Jonathan Imbody, vice president of government relations for the Christian_ Medical Association, wrote on LifeNews.com that the fact sheets contradict Plan B's abortion -inducing nature and raise questions about "whether ideological considerations are driving these decisions." A version of this article appeared in print on June 6, 2012, on page Al of the New York edition with the headline: No Abortion Role Seen for Morning -After Ru. FACEBOOK TVSTTER GOOGLE+ E-MAIL SHARE Try unlimited access to NYliimes.com for just 990. SEE OPTIONS u 640 Comments Readers shared their thoughts on this article. ALL i READER PICKS NYT PICKS Newest i Coments posed whw.nyimes.cond2012/06/06fiealtlUresearch/morning-aft-pills-dont-blodEimpiantatiorrscience-suggests.hhri?pagelnlanteci^al I& r=0 5/6 5/5/13 Get Red} E -tin ail Alerts on These Topics Plan B (Contraceptive) • Science at Issue in Debate on Morning -After Pill - NYTimes.com Birth Control and Family Planning Abortion Series Ads byGooale grain Training Games Improve memory and attention with sdentiic brain games. WWN.Iumosity.co m INSIDE NYT S.CO11i what's this? ART & DESIGN s ! 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