MODIFICATION
R -- CONSENT DECREE
- Notice Date
- 8/24/2012
- Notice Type
- Modification/Amendment
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1098941
- Point of Contact
- Vida - Niles,
- E-Mail Address
-
vida.niles@fda.hhs.gov
(vida.niles@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA) is seeking Full and Open Competition for vendors that can provide quotes/proposals. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35 This announcement constitutes the only solicitation and a written solicitation will not be issued. The synopsis, NAICS code 541990, is to notify vendors that the government intends to issue a firm fixed price Purchase Order in accordance with FAR Part 13.106, for the following statement of work, under the simplified acquisition procedures. This solicitation is issued as a Request for Quotes/Proposals. CCR: Vendor must be registered in the Central Contractor Register (CCR) prior to the award of the purchase order. You may register by going to www.ccr.gov. You will need to your Tax ID, Duns Number, Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Vida.Niles@fda.hhs.gov, no later August 15, 2012 4:30 PM EST. QUOTATIONS DUE: All quotations are to be submitted via email to Vida.Niles@fda.hhs.gov, no later than 10:00 AM, EST on August 29, 2012. Responses to this notice shall be sent via email to Vida.Niles@fda.hhs.gov, NO Telephone calls will not be accepted. REQ1098941 Statement of Work (SOW) Project Title: Development of a Strategy, Goals, Recommendations and Providing Assistance in Managing FDA's Implementation of a Consent Decree, with a Focus on Application Integrity Policy (AIP) Background The U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (as amended, May 2001) has the authority to enforce judicial actions to ensure firm's compliance with the Current Good Manufacturing Practices (21 CFR 210 and 211) for drug manufacturing and distribution of products, after a company has failed to respond to advisory action, such as untitled and warning letters. One such judicial action is an injunction, a civil judicial process initiated to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur (11 U.S.C. 332; Rule 65, Rules of Civil Procedure). An injunction may be considered for any significant out-of-compliance circumstance, but particularly when a health hazard has been identified. Proceeding by injunction does not preclude institution of additional or concurrent action such as recall, publicity, seizures, embargo by cooperating officials, or criminal prosecution. In considering an injunction, the agency must evaluate the seriousness of the offense, the actual or potential impact of the offense on the public, whether other possible actions could be as effective or more effective, the need for prompt judicial action, and whether it will be able to demonstrate the likelihood of the continuance of the violation in the absence of a court order. Injunction will be the action of choice when: a. There is a current and definite health hazard or a gross consumer deception requiring immediate action to stop the violative practice; or b. There are significant amounts of violative products owned by the same person, voluntary recall by the firm was refused or is significantly inadequate to protect the public, and seizures are impractical or uneconomical; or c. There are long-standing (chronic) violative practices that have not produced a health hazard or consumer fraud, but which have not been corrected through use of voluntary or other regulatory approaches. With respect to a. and b. above, it is helpful, but not mandatory, to show that there has been a history of prior violations, and that previous attempts to correct them through alternative warnings or sanctions have not been effective. A showing of a violative history should be made whenever possible, but especially in those cases where an imminent danger to health cannot be alleged. The U.S. Food and Drug Administration has an option to file a consent decree of permanent injunction against a company. In drafting a consent decree, Office of Chief Counsel will seek center approval on matters germane to its original review, including reconditioning or reprocessing plans, CGMP requirements, recalls, cessation of product manufacturing or distribution operations, and measures that could affect availability of medically necessary products. OCC will seek the district's approval on matters requiring district follow-up activities, such as reinspection frequency and rates, reviews of defendant's corrective actions, and witnessing destruction and disposition of goods from distributing unapproved and misbranded drugs. The consent decree often provides a series of measures that, when satisfied, will permit a firm to resume the manufacture and distribution of products marketed by itself and its subsidiaries. Additionally, as part of the consent decree, a firm may agree not to market products it manufactures until it has satisfied certain requirements designed to demonstrate compliance with FDA's current good manufacturing practices (CGMP) regulations. Finally, a drug manufacturing firm may also agree that it will not distribute certain products until the products are approved by FDA's Abbreviated New Drug Application (ANDA) or New Drug Application (NDA) processes. The Agency may also include in the Consent Decree a provision that before resuming manufacturing, a firm will have an independent third party CGMP and/or AIP expert consultant undertake a review of the firm's facilities and certify compliance with FDA's CGMP regulations and verify the reliability of data in drug application submissions. Following that certification, FDA would make a determination as to whether the firm's facilities are in compliance. Purpose/Objectives The purpose of this document is to describe the activities associated with adopting the best strategy and management in assisting the FDA staff in understanding the requirements and goals leading to a successful outcome of an AIP consent decree. Scope The Office of Compliance seeks to procure the services of a contractor to provide guidance to the Office of Compliance staff, especially the Division of Manufacturing and Product Quality and the Division of Scientific Investigations, to determine how best to manage the consent decree involving Application Integrity Policy (AIP). The AIP focuses on the integrity of data and information in applications submitted for Agency review and approval. On September 10, 1991, the FDA published the Notice of this policy formally entitled, "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities; Final Policy" (Federal Register, 56 FR 46191). The AIP describes the Agency's approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability. The FDA published the Federal Register (FR) Notice and a companion document, "Points to Consider for Internal Reviews and Corrective Action Operating Plans," in Compliance Policy Guide (CPG) 7150.09 (see Sec. 120.100 of the Compliance Policy Guides publication). Requirements Independently, and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials, services, facilities and otherwise do all the things necessary for, or incident to, the performance of the work described below. The contractor shall provide guidance on AIP elements of the consent decree for: • Third party proposals, scope and execution of data gathering and auditing, evaluation of interim and final reports, and strategic oversight; • The firm's efforts to gain the compliance with the AIP provisions; • Participation in and guidance for meetings with the firm, third party or within FDA; • Dynamic consent decree outcomes. Specific tasks that shall be performed by the Contractor include the following: Base Year tasks: For purposes of this project, specifically the management of the AIP Consent decree the work activity is subdivided into two (2) categories of applications (Type A & Type B). Category A Applications The following activities apply to category A Applications: 1. Objective: Review of third party Data Integrity Expert audits of data in the regulatory submissions that are submitted to the FDA under provisions of the consent decree. • Activities: Contractor will confirm that the third party audit has been conducted in accordance to a previously FDA approved protocol and includes all Worksheets that identify the review criteria to be used for verifying accuracy and completeness of submissions • Expected Outcome: Audit performed in its entirety according to previously FDA approved protocol • Deliverable: Written report of findings and recommendations within ten (10) business days of completion of review of audit report. 2. Objective: Ensure that third party audits fulfill the requirements as the third party Data Integrity Expert as described in the Consent Decree. • Activities: Verify that for each submission that is audited by the third party Data Integrity Expert includes a written Certification Report. • Expected Outcome: The Certification Report must indicate whether the data in each submission were found to be accurate and complete. If the audit reveals data are not accurate or complete that the audit report must provide FDA with a summary of findings. • Deliverable: Written report and recommendations within ten (10) business days of completion of review of each audit report. 3. Objective: Ensure that all Worksheets are complete. • Activities: All review criteria have been addressed • Expected Outcome: Findings are clearly and completely described, and that the Worksheets list all documents and records reviewed. Each Worksheet is initial and dated and the complete audit report (last page) is signed and dated (Reviewed By) • Deliverable: Written report and recommendations within ten (10) business days of completion of review of each audit report whether or not all review criteria were met. 4. Objective: Evaluate the data in the audit reports to determine whether such Applications contain any untrue statement and/or whether such Applications contains a pattern or practice of data irregularities. • Activities: Evaluate whether critical information, identified in the audit reports, such as identified errors in test dates and data results, specification limit changes, discrepancies contained in stability reports, unexplained repeated testing, differences between raw data and Application data, missing raw data, Laboratory Out-Of-Specification Test results and unexplained discrepancies in materials and manufacturing process and failure of a batch have been thoroughly investigated and reported accordingly. Verify if audit report includes verifiable information as to the noted discrepancies. • Expected Outcome: The audit report includes an assessment of findings and determination as to whether the finding(s) represent evidence of untrue statements and/or data irregularity. • Deliverable: An evaluation of the data to determine whether such Application contains any untrue statements and/or a pattern or practice of data irregularities. Submit a written report within ten (10) business days of completion of audit report. 5. Objective: Project Report • Activities: Submit bi-monthly written reports that include a detailed discussion of the overall process, outcomes and evaluation of the third party audit process. • Expected outcome: An assessment of the progress of the audit process. • Deliverable: Make recommendations for improvements to current execution strategy. Category B Applications The following activities apply to category B Applications: 1. Objective: Review of internal review of internal (the firm) protocols of Applications submitted to the FDA in accordance to the applicable paragraph of the consent decree. • Activities: Ensure that the reference internal protocols include all the necessary elements as described in the applicable paragraph of the consent decree. • Expected outcome: The Review Protocol includes elements 1 through 7 of 7 in accordance to the requirements of the applicable paragraph of the consent decree • Deliverable: a) Complete review within ten (10) business days of receipt from the firm of the internal review protocol; b) Report in writing the findings and recommendations; c) If deficiencies are identified submit these deficiencies in the written report with a rationale in support of FDA decision; d) If applicable, FDA will review the revised protocols and make a determination of acceptability or non-acceptability within ten (10 business days. 2 Objective: Review of the firm's Corrective Action Operation Plan (CAOP) • Activities: Ensure that each CAOP addresses the internal review findings from the involved facilities and from each of the involved applications • Expected outcome: CAOP must ensure the integrity of data submitted to FDA and at a minimum must include the requirements (1 through 6 of 6) referenced in the applicable paragraph of the consent decree • Deliverable: a) Complete review of each CAOP within fifteen (15) business days and make a determination of acceptability or non-acceptability of the submitted CAOP; b) report in writing findings and recommendations; c) If deficiencies are identified a revised CAOP will be resubmitted by the firm and reviewed by FDA within ten (10) days of receipt of revised CAOP and make a determination of acceptability or non-acceptability; d) If applicable review firm's response and submit a final recommendation to FDA within five (5) business days. Option Year tasks: Continuation of tasks described in Base Year for Type B Applications for each facility and each Application. All work shall be performed in accordance with the statement of work and all terms and conditions of this contract. The capabilities required under this contract include a thorough and comprehensive understanding of the Office of Compliance, its structure, key stakeholders, and the cross-over relationships and work process interdependencies between the Office of Compliance, other Offices within the Center, other key stakeholders within the Agency and regulated industry. Contractor Roles and Responsibilities The Contractor shall designate one or more individuals as key person(s). The Contractor shall guarantee that the FDA will not be without a Contractor key technical or management position, or mutually agreed upon alternate. Any subsequent substitution of personnel shall require express written approval from the FDA. Key Personnel The Contractor shall propose one or more key person(s), who together, must perform the following role in support of this SOW: Project Manager - Responsible for technical and management direction, submission of deliverables, and general support and coordination with the FDA Project Officer/Manager and FDA staff, as needed. This individual is fully authorized to direct and supervise day-to-day activities of Contractor and subcontractor staff needed to meet Task Order Requirements. The Contractor shall perform project management throughout the life of the contract. Consent Decree Specialist - Responsible for advising Office of Compliance on consent decree procedures and policy, application data integrity policy and assisting the Office of Compliance in drafting the CD with a goal of successful, long term outcome for the protection of public health. Contract Governance Process This contract shall be managed according to a Project Management Plan (PMP), which shall be created by the Contractor and approved by the FDA. The Contractor shall submit a Monthly Status Report to the Contracting Officer Representative (COR) for review and approval. This report shall be delivered electronically and presented orally at a regularly scheduled project status meeting. This report must specify: a. Current project performance. b. Key accomplishments and problems encountered. c. Service level, staffing, and price performance (current month and fiscal year to date): 1. Service level performance (planned versus actual). 2. Staffing and expenditures (planned versus actual). d. Key issues requiring FDA management attention. e. Productivity recommendations. f. Proposed and approved work assignments, staffing, deliverable schedule, and any outstanding requirements or issues that need to be addressed. General Support The Contractor shall provide general support for the previously defined monthly status meetings. All meetings will be located on FDA property in the DC metro area. The Contractor shall prepare meeting agendas, minutes or notes, issues and action items, distribute meeting documentation, and participate in the dissemination of information regarding the status of the project as outlined in the SOW. Deliverables The Contractor shall be responsible for completion of the following deliverables: a. Project Management Plan. This plan must describe the project management processes that organize the work, that ensure project performance information is collected and reviewed, and that ensure deliverables are completed on time. b. Project Work Plan. This work plan must include milestones, tasks and deliverables. c. Management Reports. The Contractor shall submit a Monthly Status Report describing the work performed for all tasks and resources expended to date. The Report must include a written progress report, to include accomplishments, plans, outstanding issues, and an updated project schedule. The Contractor's Project Manager shall provide the status report to the COR. One copy of each deliverable shall be provided to the COR using email and attachments and in hard-copy form (where applicable). The FDA will accept or reject the deliverables in writing. In the event of the rejection of any deliverable, the COR, giving the specific reason for the rejection, will notify the Contractor in writing. The Contractor shall have five (5) working days to correct the rejected deliverable and return it to the COR. Schedule of Deliverables. Each year, after the award of the contract or option year, the COR will develop a specific list of deliverable due dates. The following table identifies deliverables for the contract base period. Schedule of Deliverables and Services - Base Year Quantity Due Date Final Project Management Plan Within 10 days of contract award Final Project Work Plan Within 21 days of contract award Provide Management reports Monthly and a final yearly report in accordance with described schedule Review correspondence and provide either written or verbal guidance. Ongoing/Monthly Attend and participate in consent decree related meetings and provide either written or verbal guidance. Ongoing/Monthly Provide either written or verbal guidance for re-inspection of affected manufacturing and testing sites. Ongoing/Monthly Provide verbal or written guidance evaluating the validity assessment. Ongoing/Monthly Provide verbal or written guidance evaluating dynamic consent decree outcomes. Ongoing/Monthly Schedule of Deliverables and Services - Option Year One Quantity Due Date Updated Project Management Plan Within 10 days of excercizing option year one Provide Management reports Ongoing/Monthly Review correspondence and provide either written or verbal guidance. Ongoing/Monthly Attend and participate in consent decree related meetings and provide either written or verbal guidance. Ongoing/Monthly Provide either written or verbal guidance for re-inspection of affected manufacturing and testing sites. Ongoing/Monthly Provide verbal or written guidance evaluating the validity assessment. Ongoing/Monthly Provide verbal or written guidance evaluating dynamic consent decree outcomes. Ongoing/Monthly Draft Final report summarizing findings and outcomes Due 30 days prior to the end of the period of performance Final report Due 10 days prior to the period of performance Period of Performance The government anticipates a twelve month award plus one option year Location of Performance Silver Spring, MD 20993-0002. POTENTIAL AWARD WITHOUT DISCUSSIONS The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. In any event, the Government reserves the right to make an award to the best advantage of the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. Technical Evaluation Criteria (1) Technical Understanding: Proposals will be evaluated based upon the Offeror's demonstrated: (1) ability to understand government procedures and decision-making as relates to public health protection; (2) ability to understand the AIP procedure and related FDA documents; (3) knowledge of the abilities and limitations of third party auditors and pharmaceutical manufacturing and testing firms; and (4) experience evaluating clinical testing facilities; - (2) Relevant Experience: Proposals will be evaluated based upon the Offeror's demonstrated: The contractor must have documented experience in being able to understand the consent decree procedures and policy, the application integrity policy, and assist the Office of Compliance in assessing efforts to comply with the consent decree which includes a successful and sustainable outcome for the protection of public health. (a) experience in evaluating firms where AIP has been invoked; (b) experience evaluating pharmaceutical manufacturing and testing firms; (c) experience in being able to understand the consent decree procedures and policy and the application integrity policy, (d) knowledge and experience working with organizations and stakeholders in the context of FDA on implementing successful compliance strategies -. (e) knowledge and experience in dealing with non-AIP data integrity problems at pharmaceutical manufacturing and testing facilities - (3) Project Management / Work Plan: Proposals will be evaluated based upon the soundness, appropriateness and feasibility of the Offeror's plan to manage and carry out and all requirements of the project, as described in the SOW. Basis for Award: Award will be made to the party whose quotation offers the best overall value to the Government, technical and price factors considered. The Government will evaluate quotations based on the following evaluation criteria: 1) Technical Understanding `and Relevant Experience, 2) Project Management/Work Plan, and 3) Price. The Technical Understanding and Relevant Experience and Project Management Work Plan factors are of equal importance and, combined, these factors are more important than the price factor. If two or more quotations are determined to be approximately equal technically, price may become the determining factor in selecting the awardee. In any event, the Government reserves the right to make an award to the best advantage of the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CONFLICT OF INTEREST: FDA 1338 Individual Conflict of Interest As a regulatory agency charged with protection of public health, the FDA must maintain public confidence in the integrity of its decisions. The FDA has policies and procedures that safeguard against actual and apparent conflict of interest on the part of its employees. In contracting for review and evaluation of scientific data and information submitted to the agency, it is critical that the FDA be assured that there is no actual or apparent conflict of interest on the part of the individual contractor. Offers performing work under this contract must assure the protection of information and data they receive under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the contractor. DEFINITION of Conflict of Interest Conflict of interest means that because of other activities or relationships with other persons or organizations, a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR 9.501). CONTRACTOR'S CONFLICT OF INTEREST RESPONSIBILITIES The individual contractor must be free of interest prior to performing under this contract. Anytime prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the COTR. The COTR shall determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the COTR. CONFLICT OF INTEREST SCREENING An individual offeror /contractor submitting a proposal in response to this solicitation must submit the following information (if no relevant information exists, please provide a statement to that effect). 1. A list of any stock holdings and investments for you, your spouse and minor children. 2. Any positions, either compensated or not, that you currently hold (or have under negotiation). 3. Any contracts, grants, or cooperative research and development assignments that you are working on or have under negotiation; 4. Any other sources of income (not mentioned above) 5. Any other relevant information concerning any past, present, or planned interests that may have a bearing on the responsibilities described in the Performance Work Statement. The COTR shall conduct a review if the information submitted and determine if a conflict of interest exists prior to forwarding any documents to the contractor. Prior to submitting new work assignments, the COTR shall follow-up with the contractor to determine if any changes to his/her financial interest have occurred. CONFLICT OF INTEREST AGREEMENT In executing this contract, the individual contractor agrees: 1. To report to the proper authority within the FDA (the COTR), any situation or event that may constitute a conflict of interest, whether actual or potential. 2. To act impartially and not give preferential treatment to any individual or organization which has submitted applications, information, and or data. 3. Not to solicit any gift or other item, nor accept any gift or other item, of monetary value exceeding $20.00 from any person or entity seeking official action from, doing business with or conducting activities related to the evaluations and work performed under this contract. Aggregate market value of individual gifts should not exceed $50.00 in a calendar year. 4. Not to disclose any information and/or data within his or her purview, or to which he/she has access as a result of performing work under this contract. 5. Not to participate in any matter involving specific parties who are likely to or can directly affect the financial interest of a member of his household or a relative with whom they have a close personal relationship; and 6. To disqualify himself from participating in particular matters involving former employees or their representatives, with whom they have worked within the past one (1) year and who might represent a conflict of interest.
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