SOLICITATION NOTICE
R -- Legal Review for FDA Unapproved New Drug Initiative
- Notice Date
- 8/14/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541199
— All Other Legal 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
- FDA-SOL-08-00614
- Archive Date
- 9/13/2008
- Point of Contact
- Kimberly m Davis, Phone: 301-827-7179
- E-Mail Address
-
kimberly.davis@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541199, identified as FDA-SOL-08-00614, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. 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. (a) Background: For a variety of historical reasons, some drugs are available in the United States that lack required FDA approval for marketing. FDA has an interest in taking steps to either encourage the manufacturers of these products to obtain the required evidence and comply with the approval provisions of the Federal Food, Drug, and Cosmetic Act (the Act), or remove the products from the market. In June 2006, FDA stepped-up its efforts against marketed unapproved drugs by issuing a final guidance document outlining its enforcement policies aimed at efficiently and rationally bringing all such drugs into the approval process, without imposing undue burdens on consumers or unnecessarily disrupting the market. With the Compliance Policy Guide (CPG), the Agency announced a renewed focus on the problem of illegally marketed unapproved drugs and that it is committed to solving it. The Agency also provided the industry with specific notice that anyone who markets an unapproved drug is subject to enforcement action. Consistent with the Agency’s risk-based approach, the CPG gives highest priority to unapproved drugs that have safety concerns, lack evidence of effectiveness, or are health frauds. FDA estimates that, in the United States today, perhaps as many as several thousand drug products are marketed illegally without required FDA approval. Because we do not have complete data on illegally marketed products, and because the universe of such products is constantly changing as products enter and leave the market, we first have to identify illegally marketed products before we can contemplate enforcement action. Once an illegally marketed product is identified, taking enforcement action against the product would typically involve one or more of the following: requesting voluntary compliance; providing notice of action in a Federal Register notice; issuing an untitled letter; issuing a Warning Letter; or initiating a seizure, injunction, or other proceeding. Each of these actions is time-consuming and resource intensive. Included in the mix of products marketed without approval are those products considered as part of the Drug Efficacy Study Implementation (DESI). With the expansion of FDA’s authority under the 1962 amendments to the Act, FDA initiated the DESI project to evaluate the effectiveness of those drugs that had been previously approved on safety grounds alone. FDA contracted with the National Academy of Science/National Research Council (NAS/NRC) to make an initial evaluation of the effectiveness of over 3,400 products that were approved only for safety between 1938 and 1962. Drugs that were part of the DESI project, and those identical, related, and similar to them, may continue to be marketed until the administrative proceedings evaluating their effectiveness have been concluded, at which point continued marketing is only permitted if a New Drugs Application (NDA) is approved for such drugs. The vast majority of the DESI proceedings have been concluded, but a few are still pending. The pending nature of these proceedings allows manufacturers to continue to market often ineffective drug products. Legal review of the administrative records is required for the remaining pending DESI proceedings to identify and evaluate the regulatory status of these products, and draft Federal Register notices to appropriately close-out these remaining DESI proceedings. (b) Objectives: Procure the services of a person with a law degree that has proven experience, expertise, knowledge, and abilities in the following areas: (1) The Act and other statutes affecting drug products, Title 21 Code of Federal Regulations, and the policies, procedures, and guidelines applicable in determining the regulatory status of marketed products as “drugs” and “new drugs.” (2) Requirements for legally marketing drug products in the United States, including over-the-counter and prescription drug products. (3) FDA’s Compliance Policy Guide, Section 440.100, titled: Marketed Unapproved Drugs, and other agency policies affecting the marketing of drug products. (4) The Drug Efficacy Study Implementation program and status of drugs as related to DESI and pre-1938/1962 drug issues. (5) FDA policies, laws, administrative issues, enforcement procedures, and regulations for drug products pertaining to the universe of unapproved drug products and DESI drug products. (6) DESI/LTE or DESI/IRS drug products with ability to provide legal based rationale as to why a drug was evaluated as Less Than Effective (LTE) or why a drug product is Identical, Related and Similar (IRS) to a DESI/LTE drug product. (7) Administrative proceeding review, including the ability to review the docket and administrative records, provide detailed summary and legal analysis of DESI proceedings, and draft legally sustainable recommendations for determining completion. (8) Precedents established by prior FDA decision-making, enforcement actions, and court decisions affecting drug products. (9) Judicial practices and procedures for effective management of litigated cases. (10) Westlaw and/or Lexis and Internet searching skills. (c)Scope of Work/Performance Requirements and Standards: Independently and not as an agent of the US Federal Government, the Offeror shall furnish the necessary services as outlined under this Scope of Work (SOW). The requested activities will be classified into the categories described below. (1) Project Management Project management services for this work shall include development and maintenance of an overall work plan and timeline, management of overall project activities to meet this timeline, and reporting on project status on a monthly basis. This plan shall be delivered no later than 30 days after the beginning of the period of performance of this contract. a. Performance Standard •Project plan and schedule, prepared by the Contractor, delivered 30 days after effective date of contract. •Monthly status report, prepared by the Contractor, delivered on the 10th business day of each month for the previous month. b. Quality Assurance Plan •Review and inspection of project plan and schedule and any required revisions. •Review and inspection of monthly status reports submitted by the Contractor. •The Contractor, and not the government, is responsible for the management and quality control actions to meet the terms of the contract. The role of the government is quality assurance to ensure contract standards are achieved. In this contract, the Contractor’s inspection system (quality control program) is the basis for service quality. The Contractor is required to deliver only services that conform to or exceed the requirements of this contract. •The Project Officer (PO) will evaluate the performance objectives though periodic inspections of the contractor’s performance during each service month. The PO will also solicit customer input to evaluate the Contractor’s performance. The PO may conduct random evaluations. The PO should record both outstanding and unacceptable performance. (2) Document Review Review documents related to products subject to DESI proceedings to determine status of proceedings. a. Performance Standard •Project plan and schedule covering document review, prepared by the Contractor, delivered 45 days after effective date of contract. •Contractor will deliver a document summarizing the results of the document review and a description of the status of proceedings within the timeframe specified in the Project Plan and Schedule. b. Quality Assurance Plan •Review and inspection of document review plan and schedule. •Review and inspection of the document summarizing the results of the documents review. •The Contractor, and not the government, is responsible for the management and quality control actions to meet the terms of the contract. The role of the government is quality assurance to ensure contract standards are achieved. In this contract, the Contractor’s inspection system (quality control program) is the basis for service quality. The Contractor is required to deliver only services that conform to or exceed the requirements of this contract. •The Project Officer (PO) will evaluate the performance objectives though periodic inspections of the contractor’s performance during each service month. The PO will also solicit customer input to evaluate the Contractor’s performance. The PO may conduct random evaluations. The PO should record both outstanding and unacceptable performance. (3) Approach to Close-outs Develop an approach to close-out DESI proceedings, by Federal Register notice or other appropriate mechanism. a. Performance Standard •Project plan and schedule covering close-out approach to DESI proceedings, prepared by the Contractor, delivered 45 days after effective date of contract. •Contractor will present the close-out approach to DESI proceedings within the timeframe specified in the Project Plan and Schedule. b. Quality Assurance Plan •Review and inspection of the close-out review plan and schedule. •Review and inspection of the close-out approach to DESI proceedings. •The Contractor, and not the government, is responsible for the management and quality control actions to meet the terms of the contract. The role of the government is quality assurance to ensure contract standards are achieved. In this contract, the Contractor’s inspection system (quality control program) is the basis for service quality. The Contractor is required to deliver only services that conform to or exceed the requirements of this contract. •The Project Officer (PO) will evaluate the performance objectives though periodic inspections of the contractor’s performance during each service month. The PO will also solicit customer input to evaluate the Contractor’s performance. The PO may conduct random evaluations. The PO should record both outstanding and unacceptable performance. (4) Enforcement Actions Draft enforcement actions (such as Federal Register notices) and supporting documents, and provide follow-up as appropriate, including follow-up to previously published federal register notices. a. Performance Standard •Project plan and schedule covering enforcement actions, prepared by the Contractor, delivered 60 days after effective date of contract. •Contractor will deliver drafted enforcement actions and provide supporting documents. •Contractor will deliver a document summarizing follow-up activities associated with enforcement actions which include follow-up to previously published federal register notices. b. Quality Assurance Plan •Review and inspection of the draft enforcement action plan and schedule. •Review and inspection of the drafted enforcement actions and supporting documents. •Review and inspection of the follow-up activities associated with enforcement actions. •The Contractor, and not the government, is responsible for the management and quality control actions to meet the terms of the contract. The role of the government is quality assurance to ensure contract standards are achieved. In this contract, the Contractor’s inspection system (quality control program) is the basis for service quality. The Contractor is required to deliver only services that conform to or exceed the requirements of this contract. •The Project Officer (PO) will evaluate the performance objectives though periodic inspections of the contractor’s performance during each service month. The PO will also solicit customer input to evaluate the Contractor’s performance. The PO may conduct random evaluations. The PO should record both outstanding and unacceptable performance. (5) Legal Support Provide legal support for complex innovative decisions related to the unapproved new drugs initiative and enforcement actions. a. Performance Standard •Project plan and schedule covering legal support activities, prepared by the Contractor, delivered 45 days after effective date of contract. •Contractor will deliver document summarizing the legal support activities related to unapproved new drugs initiative and enforcement actions provided to the government. b. Quality Assurance Plan •Review and inspection of the legal support project plan and schedule. •Review and inspection of the document summarizing the legal support activities related to the unapproved new drugs initiative and enforcement actions provided to the government. •The Contractor, and not the government, is responsible for the management and quality control actions to meet the terms of the contract. The role of the government is quality assurance to ensure contract standards are achieved. In this contract, the Contractor’s inspection system (quality control program) is the basis for service quality. The Contractor is required to deliver only services that conform to or exceed the requirements of this contract. •The Project Officer (PO) will evaluate the performance objectives though periodic inspections of the contractor’s performance during each service month. The PO will also solicit customer input to evaluate the Contractor’s performance. The PO may conduct random evaluations. The PO should record both outstanding and unacceptable performance. (6) Program evaluation Measure results by reduction (and ultimate completion) of the number of pending DESI proceedings and the number of unapproved drug actions involving DESI drugs. a. Performance Standard •Project plan and schedule for the program evaluation on the reduction of pending DESI proceedings and the number of unapproved drug actions involving DESI drugs. •Contractor will deliver a document evaluating the status of pending DESI proceedings and the number of unapproved drug actions involving DESI drugs. b. Quality Assurance Plan •Review and inspection of the program evaluation project plan and schedule. •Review and inspection of the document evaluating the status of pending DESI proceedings and the number of unapproved drug actions involving DESI drugs. •The Contractor, and not the government, is responsible for the management and quality control actions to meet the terms of the contract. The role of the government is quality assurance to ensure contract standards are achieved. In this contract, the Contractor’s inspection system (quality control program) is the basis for service quality. The Contractor is required to deliver only services that conform to or exceed the requirements of this contract. •The Project Officer (PO) will evaluate the performance objectives though periodic inspections of the contractor’s performance during each service month. The PO will also solicit customer input to evaluate the Contractor’s performance. The PO may conduct random evaluations. The PO should record both outstanding and unacceptable performance. Deliverables: Project Management - Project plan and schedule - 30 days after effective date of contract. Status report covering: Activities completed during the prior month Activities planned for the next month. Problems/Issues Recommended Solutions. Due - Monthly, 10th business day of each month covering the previous month. Detailed Invoice, including: Hours billed by labor category, Category of work. Document Review - Project plan and schedule – Due - 45 days after effective date of contract. Document summarizing the results of the review and a description of the status of proceedings. Approach to Close-outs - Project plan and schedule – Due - 45 days after effective date of contract. Presentation of the close-out approach to DESI proceedings. Enforcement Actions - Project plan and schedule – Due - 60 days after effective date of contract. Draft of enforcement actions and provide supporting documents. Document summarizing follow-up activities associated with enforcement actions. Legal Support - Project plan and schedule – Due - 45 days after effective date of Contract. Document summarizing legal support activities. Program Evaluation - Project plan and schedule – Due - 45 days after effective date of contract. Document evaluating the status of pending DESI proceedings and the number of unapproved drug actions. Deliverables go to the project officer. Period of Performance: 12 Month Base with Four (4) 12 Month Options. Payment schedule: Payment will be made in monthly installments based on level of effort (hours worked). BEST VALUE CRITERIA BASIS FOR AWARD The Offeror should demonstrate in its proposal that the objectives in the statement of work are understood and offer a logical approach to their achievement. Award will be made to the offeror who is deemed most responsive, whose proposal conforms to all requirements, and is judged to represent the best value. To conduct a best value assessment, FDA will evaluate the offerors proposal submission based on Technical Elements, Price, and Past Performance as described below. Technical, Past Performance, and Price are of equal importance. As this is a best-value selection, the government may make tradeoffs in the factors below to arrive at a best value decision. The Government may award a purchase order on the basis of initial offers received, without discussions. Therefore, each initial offer should contain the Offeror's best terms from a cost and technical standpoint. EVALUATION CRITERIA The evaluation will be based on the completeness, thoroughness and demonstrated capabilities of the prospective Offeror in relation to the needs of the project as set forth in this combined synopsis/solicitation. Each proposal must document the feasibility of success implementation of the requirements of this combined synopsis/solicitation. The Offeror should show that the objectives stated in the proposal are understood and offer a logical program for their achievement. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. Offerors should provide information on all of the following criteria. A). Technical Solution Offerors shall demonstrate a thorough understanding of the scope and complexity of the Performance Work Statement. The Offeror shall, through a detailed technical proposal, be able to thoroughly explain the services the Government is seeking to obtain through this requirement. The Offeror, through its proposal, shall explain how it intends to obtain this product within the given time frame and in the most efficient and cost- productive manner. The Offeror must also show in its proposal the efforts required by the Government in order for the contractor to complete this requirement. Corporate Capability and Expertise Offerors must demonstrate the organizational resources, capability and experience to efficiently manage a requirement of this magnitude. Proposals must demonstrate substantial and successful experience in performing other efforts of a similar nature and magnitude. Proposals must also include resumes for all staff proposed that clearly demonstrate the requisite level of experience and expertise to accomplish the requirements of this purchase order outlined below. Qualifications: Proven experience, expertise, knowledge, and abilities in the Act and other statutes affecting drug products, Title 21 Code of Federal Regulations, and the policies, procedures, and guidelines applicable in determining the regulatory status of marketed products as “drugs” and “new drugs. Thorough knowledge of the requirements for legally marketing drug products in the United States, including over-the-counter and prescription drug products. Proven experience and knowledge in the review and application of Government’s Compliance Policy Guide, Section 440.100, titled: Marketed Unapproved Drugs, and other agency policies affecting the marketing of drug products. Thorough knowledge, experience, and expertise of the Drug Efficacy Study Implementation program and status of drugs as related to DESI and pre-1938/1962 drug issues. Proven experience, expertise, knowledge, and abilities of Government policies, laws, administrative issues, enforcement procedures, and regulations for drug products pertaining to the universe of unapproved drug products and DESI drug products. Thorough knowledge of DESI/LTE or DESI/IRS drug products with ability to provide legal based rationale as to why a drug was evaluated as LTE or why a drug product is IRS to a DESI/LTE drug product. Experience in administrative proceeding review, including the ability to review the docket and administrative records, provide detailed summary and legal analysis of DESI proceedings, and draft legally sustainable recommendations for determining completion. Thorough knowledge in precedents established by prior Government decision-making, enforcement actions, and court decisions affecting drug products. Thorough knowledge of judicial practices and procedures for effective management of litigated cases. Experience and expertise in Westlaw and/or Lexis and Internet searching skills. Implementation Plan Offerors must demonstrate a logical and effective planned approach for the use and management of personnel and resources required in the performance of this purchase order. Offerors must describe how these personnel and resources will be used to accomplish the specific elements of this task order. Past Performance Evaluation FDA will evaluate the offeror's past performance in the conduct of similar tasks and their relevance to this acquisition. PAST EXPERIENCE: The contractor must be able to demonstrate past experience directly relevant to the types of work needed. Such experience includes projects performed in the past five years similar in scope to the requirements of this combined synopsis/solicitation. Price FDA will evaluate the offeror's submission/proposal on their ability to provide support at a reasonable and realistic price (to include any discounts offered). Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your DUN and Bradstreet number and banking information. The anticipated award date is 09/05/2008. The following FAR clauses apply to this combined synopsis/solicitation. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items,52.217-8 Option to Extend Services (Nov 1999) and 52.217-9 Option to Extend the Term of the Contract (Mar 2000), All information received by 2:00pm EST on August 29, 2008 will be considered by the Government. All questions must be emailed no later than August 21, 2008 to kimberly.davis@fda.hhs.gov All proposals must be emailed to patricia.pembertona@fda.hhs.gov and kimberly.davis@fda.hhs.gov
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=ea020bc13a7465823e4a444cb925baf5&tab=core&_cview=1)
- Record
- SN01640798-W 20080816/080814223933-ea020bc13a7465823e4a444cb925baf5 (fbodaily.com)
- Source
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FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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