Drug Consulting Blueprint Network
Added: Jul 21, 2014 8:12 am THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED.This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The Solicitation Number for this acquisition is HHS-NIH-NIDA-(SSSA)-14-431 and is being issued as a Request for Proposal (RFP). The solicitation documents and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) 2005-74 effective July 1, 2014. This acquisition is unrestricted.The North American Industry Classification System (NAICS) Code for this procurement is 541690 and the Small Business Size Standard is 14 million dollars; Other Scientific and Technical Consulting Services.STATEMENT OF OBJECTIVESThe NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific disciplines to provide leadership and technical guidance on drug discovery and development projects in the Blueprint Neurotherapeutics Network and possibly other NIH neuroscience-focused drug discovery and development programs.• Chemical Manufacturing and Controls (CMC/Pharmaceutics) • Process Chemistry• Medicinal Chemistry• Regulatory Affairs• Bioactivity Assay Development• Toxicology• Drug Metabolism and Pharmacokinetics• Phase I Clinical ConsultantSTATEMENT OF WORKThe NIH Blueprint for Neuroscience (BPN) Research is a consortium of 15 NIH Institutes and Centers that support neuroscience research, established the Neurotherapeutics Network as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and CRO support tough phase I clinical testing. Each project is directed by a Lead Development Team composed of the principal investigator, industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by contract research providers. Bioactivity and efficacy studies are funded tough an award to the principal investigator; other research services are provided without cost to the PI tough NIH contracts.Each consulting contract will be specific to one or more areas of expertise as outlined in this Statement of Work, and will reflect the NIH time commitment needs for the specific areas of expertise. Consultants hired under this requirement will not only make significant contributions to promising drug discovery projects that have been selected tough a rigorous peer-review process, they will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts.Contract consultants will be expected to provide feedback and guidance on projects to the NIH and to Blueprint Lead Development Team (LDT) members tough conference calls and by email. Consultants may serve on an ad hoc basis or as members of LDTs. Consultants will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects.The BPN currently has projects in the exploratory tough lead-optimization stages. Some projects will proceed to the candidate selection, IND, and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. Since 2011, fifteen projects have entered the BPN, and seven have been discontinued based on milestone evaluations.General RequirementsConsultants may serve on Blueprint Lead Development Teams (LDTs), which require a regular time commitment of 3-10 hours per week, including meeting and preparation time. Each LDT meets for approximately 2 hours every 1-2 weeks by teleconference. Consultants may be asked to serve as co-chairs of LDTs.A consultant serving as an LDT co-chair shall facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the principal investigator on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role.A teleconference call with all consultants is held twice per month to discuss programmatic issues of broad interest.For a complete description, specification, experience requirements, and level of effort refer to attachment number one - Statement of Work of this solicitation.The following attachments are provided to assist you in preparing your proposal responding to this solicitation.Attachment No. 1: Statement of WorkAttachment No. 2: Invoice InstructionsAttachment No. 3: Security ClausesAttachment No. 4: Evaluation CriteriaAttachment No. 5: SF 1449 Pricing SheetThe following Provisions and Clauses apply to this RFP:FAR 52.212-1 Instruction to Offerors-/Commercial Items (FEB 2012FAR 52.212-2 Evaluation - Commercial Items (Jan 1999),(a) 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 shall be used to evaluate offers: (End of provision)For the detailed evaluation criteria (mandatory and general) please refer to attachment number 5 of the solicitation.Award Criteriaa. The acceptability of the technical portion of each contract offer will be evaluated by a technical review committee. The committee will evaluate each offer in strict conformity with the evaluation criteria of the solicitation. The committee may suggest that the Contracting Officer request clarifying information from an offeror.b. The business portion of each contract offer will be evaluated for reasonableness of the Offeror's firm to supply the services required.c. The selection for award will be based on the offer that proposes the best value to the Government.Potential Award Without DiscussionsThe Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial prices are fair and reasonable and that discussions are not necessary.FAR 52.212-4 Contract Terms and Conditions Commercial Items (FEB 2012),FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Sept 2013).The following clauses are applicable to this requirement and they are listed by reference:52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate 1 (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).52.219-6, Notice of Total Business Set-Aside (Nov 2011) (15 U.S.C. 644).52.223-18, Encouraging Contractor policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).FAR 52.222.17, Non-displacement of Qualified Workers (May 2014).The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract in full text, to implement provisions of law or Executive orders applicable to acquisitions of commercial items.52.217-5 Evaluation of Options (JULY 1999)Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s). (End of provision) 52.217-6 Option for Increased Quantity. (MAR 1998)The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within the current period of performance. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree. (End of clause)FAR 52.217-8 Option to Extend Services (Nov 1999)The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days from the expiration of the current contract period of performance.(End of clause)52.217-9 Option to Extend the Term of the Contract (Mar 2000)(a) The Government may extend the term of this contract by written notice to the Contractor within the current period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months. (End of clause) Contracting Officer's RepresentativeThe following Contracting Officer Technical Representative (COR) will represent the Government for the purpose of this contract:To be determined at the time of award.The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.The Government may unilaterally change its COTR designation.Post Award evaluation of Contractor Performancea) Contractor Performance EvaluationsInterim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted at the time of the annual evaluation. Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation.The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations Contractor responses and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.b) Electronic Access to Contractor Performance evaluationsContractors that have internet capability may access evaluations tough a secure Web site for review and comment by completing the registration form that can be obtained at the following address: hhtp://oamp.od.nih./OD/CPS/cps.asp. The registration process requires the Contractor to identify an individual that will serve as a primary point of contact and who will be authorized access to the evaluations for review and comment. In addition, the Contractor will be required to identify an alternate contact that will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.Reporting Matters Involving Fraud, Waste and AbuseAnyone who becomes aware of the existence or apparent fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector general's Office in writing or the Inspector general's hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The email address is Htips@os.dhhs.gov and the mailing address is:Office of the Inspector generalDepartment of Health and Human ServicesTIPS HOTLINEPO Box 23489Washington, DC 20026ADDITIONAL PROPOSAL INSTRUCTIONS:Full text copies of the representations and certifications for the other cited provisions and clauses may be obtained online at the NCI website at http://amb.nci.nih.gov.The following instructions will establish the format and contents of Offers. Special attention is directed to the Fixed Price for technical and business offers to be submitted in accordance with these instructions.1 Contract Type and General ClausesIt is contemplated that a Firm Fixed Price contract will be awarded. Any resultant contract shall include the clauses applicable to the selected offerors organization and type of contract awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed contract.2 Authorized Official and Submission of OffersThe offer must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this COMBINED SOLICITATION\SYNOPSIS. Your offer shall be submitted as fololows:1. USPS\FedEx\UPS\Courier - One original and tee copies2. Electronic - One copy and one original mailed to the appropriate address within 24 hours of the closing of the solicitation.Offers will be typewritten, paginated, reproduced on letter size paper and will be legible in all required copies. To expedite the offer evaluation, all documents required for responding to the Solicitation should be placed in the following order:I. COVER PAGEInclude Solicitation title, number, name of organization, identification of the offer part, and indicate whether the offer is an original or a copy.II. TECHNICAL OFFERIt is recommended that the technical offer consist of a cover page, a table of contents, and the information requested in the Technical Offer Instructions. III. BUSINESS OFFERIt is recommended that the business offer consist of a cover page, a table of contents, and the information requested in the Business Offer Instructions.3 Separation of Technical and Business OffersThe offer must be prepared in two parts: a "Technical Offer", and a "Business Offer" (maybe contained in one binder with two separate sections). Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The technical offer may include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the offerors understanding of the project may be evaluated, but should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any)., and total costs. The technical offer should disclose your technical approach\expertise in as much detail as possible, including, but not limited to, the specific discipline(s) you are submitting for, should clearly demonstrate the offerors capabilities, knowledge, and corporate capability and experience related to supply the services as described in the Statement of Work. The technical offer should be in as much detail as is considered necessary to provide straightforward, concise delineation of the approach the offeror will use for accomplishing the work and how the project is to be managed and staffed. Stating that the offeror understands and will comply with theNOTE: THE TECHNICAL OFFER AND OTHER INFORMATION RELATED TO HOW THE OFFEROR(S) DIRECTLY RELATES TO THE SCOPE OF WORK IN THIS SOLICITATION AND SHALL NOT EXCEED 50 SINGLE-SIDED PAGES. Pages in excess of the limitation may neither be read or evaluated. Each page of the technical offer must be numbered sequentially. Offerors are encouraged to limit the overall size of the technical offer, inclusive of appendicesPast Performance Informationa) Offerors shall submit the following information as part of their BUSINESS offer.A list of the last tee ( 3) contracts completed during the past tee (3) years and ALL CONTRACTS currently being performed that are similar in nature to the solicitation work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a major subcontract is defined as a subcontract that exceeds $500,000.Include the following information for each contract or subcontract:1. Name of Contracting Organization2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number)3. Contract Type4. Total Contract Value5. Description of Requirement6. Contracting Officer's Name and Telephone Number7. Program Manager's Name and Telephone Number8. North American Industry Classification System (NAICS) CodeThe Offeror may provide information on problems encountered on the identified contracts and the offerors corrective actions.b) The Government is not required to contact all references provided by the offeror.Basic Cost/Price InformationThe business offer must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required services. This information shall include a current financial statement of the firm responding.The cost information should be submitted on the SF 1449 that is attached to this solicitation.The Offeror must submit with its proposal;Please note that Offerors must either complete FAR 52.212-3, Offerors Representation and Certifications - Commercial Items (Aug 2009) or provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management Applications (SAM) with their technical/business proposal submission.Questions regarding this combined synopsis/solicitation must be received in this office by August 8, 2014. Offers must be received by 10:00 AM. (EST) August 20, 2014.Submit offers to:Mr. Brian J. LindContract SpecialistNational Institutes of HealthNational Institute on Drug AbuseStation Support Contracts\Simplified Acquisitions BranchBuilding, 31 Room 1B59 MSC 2080Bethesda, MD 20892-2080Please reference the solicitation number HHS-NIH-NIDA-(SSSA)-14-431 on your offer.Proposals may be sent electronically to LINDBJ@NIH.NIDA.GOV. If you sent it electronically one original proposal must be received at the address above within 48 hours of solicitation closing.Facsimile submissions are not authorized and collect calls will not be accepted.
HHS-NIH-NIDA(SSSA)-14-431 Department of Health and Human Services National Institutes of Health
7/21/14, 8:12 AM