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FBO DAILY ISSUE OF SEPTEMBER 06, 2008 FBO #2476
SOLICITATION NOTICE

R -- MEDICAL REVIEWER

Notice Date

9/4/2008
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
 

ZIP Code

72079-9502
 

Solicitation Number

FDA-SOL-08-00884
 

Archive Date

9/27/2008
 

Point of Contact

Regina R. Williams,, Phone: (870) 543-7012, Sandra K. Davis,, Phone: (870) 543-7469
 

E-Mail Address

regina.williams@fda.hhs.gov, sandra.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 Subpart 12.6, in conjunction with FAR 13.5 as applicable and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. This is a Request for Quotations (RFQ); a written solicitation will not be issued. The Food and Drug Administration, Center for Drug Evaluation and Research has a requirement for the services listed below. This a 100% small business set-aside. The solicitation number is FDA-SOL-08-00884. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-26, June 12, 2008. The associated North American Industry Classification System (NAICS) Code is 541990 – and the size standard is $6.5million. The Food and Drug Administration, Center for Drug Evaluation and Research has a requirement for a Medical Reviewer. (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. New drugs as defined by section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) must obtain applications. Under section 201(p) of the Act any drug is a “new drug” unless it is “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.” This standard is often referred to by the shorthand “generally recognized as safe and effective” or abbreviation GRAS/E. In order to be GRAS/E within the meaning of 21 U.S.C. § 321(p)(1), a drug must satisfy three criteria. First, the particular drug product at issue must have been subjected to adequate and well controlled clinical investigations which might establish that the product is safe and effective. Second, those investigations must have been published in the scientific literature so that they are available to qualified experts. Third, experts must generally agree, based on those published studies, that the product is safe and effective for its intended uses. A product’s general recognition as GRAS/E must be evidenced by at least the same quality and quantity of data as are necessary to support approval of an NDA. OBJECTIVES: Procure the services of a person with regulatory, compliance, public health experience, and a medical degree that has proven experience, expertise, knowledge, and abilities in the following areas: (1) The Act Title 21 Code of Federal Regulations, and the policies, procedures, and guidelines applicable in determining the characteristics of adequate and well-controlled clinical investigations. (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) In Depth understanding of section 201(p) of the Federal Food, Drug, and Cosmetic Act and its application in the determination of GRAS/E. (5) FDA policies, laws, administrative issues, enforcement procedures, and regulations for drug products pertaining to the universe of unapproved drug products and GRAS/E. (6)Experience reviewing, evaluating, or preparing FDA’s New Drug Application (NDA), Investigational New Drug Application (IND), and supplements process. (7) Experience in searching established medical literature databases. (8) Precedents established by prior FDA decision-making, enforcement actions, and court decisions affecting drug products. (9) Knowledge of FDA’s Drug Shortage Program and the determination of medically necessary drugs. (10) Experience reviewing Federal Register Notices and other regulatory documents. (11) Experience developing protocols for clinical trials. (B) COMPENSATION - FIXED-PRICE SCHEDULE - A. As consideration for the services described in C-I, "Scope of Work," the Government shall pay to the Contractor the fixed price of $________________. Base Year (September 22, 2008 through September 21, 2009) Description Quantity Unit Price: 1. Project Management, Literature Review, Strategy Development, Identification of Obstacle(s) to obtaining approval, and GRAS/E Review. Level of Effort -estimated 398 hours. 12 Months $_______ Option Year I (September 22, 2009 through September 21, 2010) Development of documents to support the strategy, Prepare protocols for clinical trials, and GRAS/E Review. Level of Effort - estimated 398 hours. Description Quantity Unit Price: 12 Months $________ (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. BASE YEAR: (1) Project Management - 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. Monthly status reports, to include number of hours worked. 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) Literature Review – Collect all relevant data and information on the drug class or product identified and evaluate the data as it relates to clinical safety and efficacy of the products. a. Performance Standard: • Project plan and schedule covering document review, prepared by the Contractor, delivered 30 days after effective date of contract. • Contractor will establish literature search criteria and deliver 30 days after effective date of contract. • Contractor will evaluate literature search and prepare summary of literature search and deliver 120 days after effective date of contract. • Contractor will deliver a document containing the results of the literature review with supporting documents b. Quality Assurance Plan: • Review and inspection of the literature review project plan and schedule. • Review and inspection of the document containing the results of the literature 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) Strategy Development – Identify incentives and innovative regulatory strategies that could be employed to encourage firms to submit applications and obtain approval for specific medically necessary drugs. a. Performance Standard: •Project plan and schedule for the identification of incentives and regulatory strategies prepared by the Contractor, delivered 60 days after effective date of contract. •Contractor will development a strategy to encourage firms to apply and obtain approval for specific medically necessary drugs 180 days after effective date of contract. •Contractor will present and deliver a document detailing the identified incentives and innovative regulatory strategies that could be employed to encourage firms to obtain approval for medically necessary drugs within the timeframe specified in the Project plan and schedule. b. Quality Assurance Plan: • Review and inspection of the incentive development and strategy plan and schedule. • Review and inspection of the proposed incentives and regulatory approach. • 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) Identification of obstacle(s) to obtaining approval – Perform research necessary to identify the obstacle(s) to obtaining approval specifically for medically necessary drugs. a.Performance Standard: • Project plan and schedule for performing the research to identify obstacle(s) to obtaining approval, prepared by the Contractor, delivered 60 days after effective date of contract. • Contractor will present the identified obstacle(s) to obtaining approval specifically for medically necessary drugs within 180 days after effective date of contract. b. Quality Assurance Plan: • Review and inspection of the research plan and schedule. • Review and inspection of the identified obstaclesto obtaining approval. • 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. OPTION YEAR I: (5) Development of documents to support strategy – Develop the specific documents, including but not limited to guidelines, federal register notices and draft regulations that implements the strategy to streamline the application process and identify for firms the requirements for obtaining approval of specific medically necessary drugs. a. Performance Standard: • Project plan and schedule detailing the development of documents to support the strategy to streamlined application and approval processes, prepared by the Contractor, delivered 60 days after effective date of contract. • Contractor will deliver completed supporting documents and identified streamlines strategy of the application and approval process 90 days after effective date of contract. • Contractor will deliver Federal Register Notice, Guidance, or regulation 220 days after effective date of contract. • Contractor will deliver supporting documents utilized in the development of the specific documents. b. Quality Assurance Plan: • Review and inspection of the project plan and schedule for the development of the specific documents. • Review and inspection of the draft supporting documents setting forth the application and approval process for medically necessary 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. (6) Prepare protocols for clinical trials – Evaluate data and prepare protocols for clinical trials. If necessary develop specific protocols for clinical trials on medically necessary drugs. a. Performance Standard: • Project plan and schedule detailing the evaluation of data and preparation of protocols, prepared by the Contractor, delivered 60 days after effective date of contract. • Contractor will deliver a protocols for clinical trials and if necessary specific protocols for clinical trials on medically necessary drugs 220 days after effective date of contract. • Contractor will deliver supporting documents utilized in the development of the protocols. b. Quality Assurance Plan: • Review and inspection of the project plan and schedule for development of the protocols. • Review and inspection of the protocols and supporting data. • 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. BASE YEAR AND OPTION YEAR I (7) Generally Recognized as Safe and Effective (GRAS/E) review – The Project Officer will request. Evaluate products to determine if they are GRSA/E as outlined in 21 U.S.C. § 321(p) (1). a. Performance Standard: • Project plan and schedule for GRAS/E review, prepared by the Contractor, delivered 30 days after date of request. b. Quality Assurance Plan: • Review and inspection of the GRAS/E project plan and schedule. • Review and inspection of the documents containing the results of the GRAS/E review with supporting documents. • 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 at a minimum: Activities completed during the prior month, Number of hours worked on each activity, Activities planned for the next month. Problems/Issues Recommended Solutions, and Detailed Invoice, including: Hours billed by labor category, category of work - Due - Monthly, 10th business day of each month covering the previous month. Literature Review - Project plan and schedule and Literature search and criteria – Due - 30 days after effective date of contract. Final literature search and summary of literature search – Due – 120 days after effective date of contract. Strategy Development – Project plan and schedule and Literature search and criteria – Due - 30 days after effective date of contract. Document detailing the identified incentives and innovative strategies that could be employed to encourage firms to apply and obtain approval for medically necessary drugs – Due – 180 days after effective date of contract. Identification of obstacles to obtaining approval - Project plan and schedule – Due 60 days after effective date of contract. Presentation of identified obstacle(s) to obtaining approval specifically for medically necessary drugs – Due -180 days after effective date of contract. Development of documents to support the strategy – Project plan and schedule – Due – 60 days after effective date of contract. Completed supporting documents and identified streamlined strategy of the application and approval process- Due – 90 days after effective date of contract. Completed Federal Register Notice, Guidance, or regulation – Due – 220 days after effective date of contract. Prepare protocols for clinical trials - Project plan and schedule – Due - 60 days after effective date of contract. Completed protocols for clinical trials and if necessary specific protocols for clinical trials on medically necessary drugs – Due – 220 days after effective date of contract. GRAS/E Review – Project plan and schedule – Due 30 days after date of request. Release of Information: All data used and generated by the contractor is and remains the property of the Food and Drug Administration. Government Support: The Government will provide necessary equipment such as computer and other supplies needed to complete the project. Arrange for office space (if necessary). Coordinate travel (if necessary). PERIOD OF PERFORMANCE: Base Year with one (1) Option Year: Base Year – September 22, 2008 – September 21, 2009 Option Year I – September 22, 2009 – September 21, 2010 Payment schedule: Payment will be made in monthly installments based on level of effort (hours worked). Invoices are to be submitted to the assigned FDA Project Manager, for approval. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations, or reject the terms and conditions of the solicitation, may be excluded from consideration. Contract type: Commercial Item – Firm Fixed Price. Simplified procurement procedures will be utilized. FOB Point of Delivery for services and reports provided will be the Food and Drug Administration, Center for Drug Evaluation and Research, Attn: Steven Lynn, RM5192 HFD-300, 10903 New Hampshire Avenue, Silver Spring, MD 20993. The provision at FAR 52.212-1 Instructions to Offerors – Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None. The provision at FAR 52.212-2 Evaluation – Commercial Items is applicable to this solicitation. The specific evaluation criteria to b included in paragraph (1) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate offers: Technical, Price and Past Performance. Technical and Past Performance, when combined, are equal to price. Technical acceptability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the contractor can meet the Government’s requirement. 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. 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 evaluation criteria listed below. The following evaluation criteria will be used: EVALUATION CRITERIA: The Act, Title 21 Code of Federal Regulations, and the policies, procedures, and guidelines applicable in determining the characteristics of adequate and well-controlled clinical investigations (30 Points). Requirements for legally marketing drug products in the United States, including over-the-counter and prescription drug products (10 Points). FDA’s Compliance Policy Guide, Section 440.100, titled: Marketed Unapproved Drugs, and other agency policies affecting the marketing of drug products (10 Points). In depth understanding of section 201(p) of the Federal Food, Drug, and Cosmetic Act and its application in the determination of GRAS/E (10 Points). FDA policies, laws, administrative issues, enforcement procedures, and regulations for drug products pertaining to the universe of unapproved drug products (10 Points). Experience preparing or reviewing FDAs New Drug Application (NDA/Abbreviated New Drug Applications (ANDA) (15 Points). Experience in searching established medical literature databases (e.g., PubMed, Medline) (5 Points). Precedents established by prior FDA decision-making, enforcement actions, and court decisions affecting drug products (5 Points). Knowledge and experience in developing protocols for clinical trials (5 Points). Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications- Commercial Items with its offer. The full text of this clause can be located at: www.acqnet.gov/FAR. The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes of Executive Orders – Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6; 52.219-6; 52.219-8; 52.222-3; 52.222-21; 52.222-26; 52.222-35; 52.222-36; 52.222-37; 52.223-9; 52.222-50; 52.225-1; 52.225-13, and 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov. 52.217-8 Option to Extend Services 52.217-9 Option to Extend the Term of the Contract CCR Requirement – Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. It is the offeror’s responsibility to monitor the FedBizOpps website for any released amendments to the solicitation. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. All responsible sources may submit a quotation, which if received timely, shall be considered by the Agency. Offers must be submitted on SF1449, which can be located at http://www.gsa.gov/Portal/gsa/ep/formslibrary.doformType=SF and reference solicitation number FDA-SOL-08-00884. Offers are due in person, by mail or fax on or before September 12, 2008 by 3:00 pm (Central Standard Time – Local Prevailing Time in Jefferson, Arkansas), at Food and Drug Administration OC/OSS/OFFAS, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Regina Williams @ (870) 543-7012, FAX (870) 543-7990, email regina.williams@fda.hhs.gov.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=8a6cbd9632c0e5179bc3f1347aa4ea96&tab=core&_cview=1)
 

Place of Performance

Address: 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN01660369-W 20080906/080904223133-8a6cbd9632c0e5179bc3f1347aa4ea96 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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