SOLICITATION NOTICE
R -- Regulatory Affairs Consulting Services for NINDS Biotechnology Products and Biologics - Copy of Solicitation
- Notice Date
- 5/11/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-CSS-16-287
- Archive Date
- 6/28/2016
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Appendix A: Applicable IT Security Clauses Copy of Solicitation Regulatory Affairs Consulting Services for NINDS Biotechnology Products & Biologics Competitive Combined Synopsis/Solicitation HHS-NIH-NIDA-SSSA-CSS-16-287 INTRODUCTION This is a combined synopsis/solicitation for commercial items 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. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures, FAR Subpart 13.5--Test Program for Certain Commercial Items, and FAR Part 12--Acquisition of Commercial Items. The solicitation number is HHS-NIH-NIDA-SSSA-CSS-16-287 and the solicitation is issued as a request for proposal (RFP). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690 with a Size Standard of $14 Million. SET-ASIDE STATUS This acquisition is unrestricted and available for full and open competition. ACQUISITION AUTHORITY This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, FAR Subpart 13.5--Test Program for Certain Commercial Items, and FAR Part 12-Acquisition of Commercial Items, and IS expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-87-2 dated April 6, 2016. The resultant contract will include all applicable provisions and clauses in effect through this date. DESCRIPTION OF REQUIREMENT Background The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. NINDS intramural labs are headed by federal employees who work for the Institute, primarily located in Bethesda, MD. For more information on the NINDS Intramural program visit the website http://dir1.ninds.nih.gov/ninds/Home.aspx For extramural research, NINDS awards grants and cooperative agreements to outside academic institutions, small business concerns and other organizations all over the U.S. and world to fund promising basic, translational, and clinical research projects. Specifically, the NINDS Office of Translational Research (OTR) is committed to facilitate the translation of basic discoveries into the development of new therapeutic interventions through early nonclinical development and early clinical investigation. For more information about the Office of Translational Research visit the website http://www.ninds.nih.gov/funding/areas/translational_research/index.htm Projects that are funded through a cooperative agreement award mechanism are led by the principal investigators (PI) team with NINDS program staff participation in guiding the project plan. The PI's team performs all of the experiments while NINDS role is to establish performance milestones for each project to facilitate go/no-go decision making and then monitor research progress and achievement of project milestones. Purpose The NINDS is seeking senior-level, industry-experienced discovery and development Biologics Regulatory Affairs consultants with expertise in biotechnology products and biologics to assist NINDS program staff to vet and advance only the most promising therapeutic biologics through the discovery and development pipeline. Both individual subject matter experts and multidisciplinary teams from consulting firms are encouraged to apply. The NIH anticipates possibly awarding multiple requirements-type consulting awards in reference to this requirement. Approximately two, and a maximum of three, awards are anticipated. Scope of Work Biologics regulatory affairs consultant(s) shall provide the following services: •Advise NINDS staff on Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulatory guidelines, regulations, and requirements pertaining to the early nonclinical and early clinical development of biologics •Review and assess data and project related proposals, and advise on study requirements to file an IND package for a range of potential biologics therapeutic modalities in nonclinical IND-enabling development - such as peptides, antibodies, recombinant proteins, oligonucleotides, cell and gene therapies - based on regulatory precedence and compliance to Common Technical Document (CTD) format requirements, including: oReview of administrative information (e.g. target product profiles, clinical protocols, and investigator information) oReview of animal pharmacology and toxicology study results to assess whether the product is expected to be reasonably safe for initial testing in humans oDetermine if previous relevant human experience is available for similar biologics or research and report results from relevant clinical trials conducted both inside and outside of the US. oReview chemistry, manufacturing and control (CMC) nonclinical study plans and results pertaining to the composition, manufacturing, testing, stability and controls for a range of biologics to assess compliance to regulatory guidance. oReview clinical protocols and investigator information to assess adherence to investigational regulations and study protocols as it pertains to a biologic modality in each case. oIntegrate regulatory guidance with research plans to advance translational research objectives. •Provide guidance to the preparation of pre-IND and IND Meetings or review FDA responses to recommend new course of action. •Review, identify and assess regulatory risks and gaps to IND-enabling research study plans and recommend solutions •Provide oral presentations in area of expertise as requested •Communicate effectively both orally and in writing Each consultant is expected to provide technical guidance and advice on advancing discovery and development projects through early nonclinical development and submission of an Investigational New Drug (IND) package, and in some cases, design of early clinical protocol and launch of a first in human clinical trial. Consulting services will be for NINDS biologics-focused projects or any other NIH program with similar needs as outlined in the scope of this statement of work. Consulting advice and guidance shall be required to supplement NINDS program experience from the pre-application stage and then throughout the life of each project to review and monitor progress. Consultants will serve as a resource to NINDS staff from the start of early discovery stage projects to structurally modify and optimize design characteristics of leads through IND-enabling activities necessary to advance potential development candidates through scale up, and early phase clinical trials. Consultants will be expected to provide feedback and guidance on projects to NINDS staff through written documents, conference calls, and by email. The consultants' major responsibility will be in offering review, guidance and advice on projects. They will be expected to offer technical review and feedback on project milestones, progress reports, or development plans, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. On rare occasion, consultants may be asked to give oral presentations to NINDS staff or at an NINDS sponsored webinar, workshop or conference to provide training to investigators in their area of expertise. Consultants may be involved in multiple projects. Each project team is led by a PI and supported by NINDS staff with disease and therapy development expertise. The joint team establishes project milestones and monitors progress at least annually. The PIs conduct all of the research activities and report progress to NINDS. NINDS staff will interact directly with the PI and request assistance from consultants to review and provide expert advice on specific topics. Consultants shall directly advise NINDS staff, and in some cases communicate directly with the PI on team calls. Key Personnel Requirements Consultant(s) working under this effort shall be considered key personnel. Key Personnel requirements are as follows: a)A minimum of an undergraduate degree in a relevant scientific discipline. b)A minimum of 10 years' experience in the biotechnology, pharmaceutical industry or regulatory industry. c)A minimum of 2 years hands-on and in-depth consulting experience in early nonclinical and early clinical development of biologics. The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows: The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty day notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. The individual(s) considered to be essential to the work being performed shall be identified in any award(s): Collaboration It is required that all contractors involved with the NINDS community work collaboratively with federal staff and other contractors towards the NINDS mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Level of Effort The NIH estimates that individual consultants or multidisciplinary teams from consulting firms shall be able to perform the required services. More than one award may be made in relation to this requirement. The estimated level of effort for the overall five year contract is as follows: Overall Contract Requirements (Over 5 Years) Minimum Quantity Maximum Quantity 30 Hours 900 Hours The minimum number of hours shall be guaranteed at time of award. The first task orders issued against the contracts awarded will be for the minimum number of hours (30). Additional hours up to the noted maximum may or may not be added to the award at the Government's discretion at the award's negotiated hourly rate. Additional hours shall be ordered via additional task orders against the awarded contracts. Annually, no more than 180 hours may be ordered. The overall contract requirements broken out by contract year are detailed below. Please note that requirements-type contracts do not contain option periods but may contain different pricing for each contract year. August 1, 2016 through July 31, 2017: Minimum of 30 hours up to 180 hours August 1, 2017 through July 31, 2018: Minimum of 0 hours up to 180 hours August 1, 2018 through July 31, 2019: Minimum of 0 hours up to 180 hours August 1, 2019 through July 31, 2020: Minimum of 0 hours up to 180 hours August 1, 2020 through July 31, 2021: Minimum of 0 hour up to 180 hours Ordering and Receiving: The maximum quantity that the Government may order over the life of the IDIQ contract is detailed in the table below. The minimum quantity which may be ordered for the life of the contract is detailed in the same table. Overall Contract Requirements (Over 5 Years) Minimum Quantity Maximum Quantity 30 Hours 900 Hours Orders issued under this contract may be placed in writing or via electronic mail (e-mail) by the authorized designee(s). The authorized designee(s) shall be identified at time of award. The Contractor representative(s) authorized to receive and accept orders shall be identified at time of award. All orders delivered under this contract must be verified by the authorized Federal designee(s). The authorized Federal designee shall formally document all work performed by the Contractor and the Contractor shall assist in this process. Period of Performance This Requirements/Indefinite-Delivery Indefinite-Quantity requirement shall have a period of performance from August 1, 2016 through July 31, 2021. Hourly rates for each year within the period of performance may be separately priced. Should Offeror's propose different hourly rates for each year, please propose them for the following periods: August 1, 2016 through July 31, 2017 August 1, 2017 through July 31, 2018 August 1, 2018 through July 31, 2019 August 1, 2019 through July 31, 2020 August 1, 2020 through July 31, 2021 Place of Performance The contractor shall provide services remotely from its own site. Travel Under special circumstances, the consultant(s) may be asked to give presentations in their area of expertise to train program staff or investigators. Travel reimbursement will be provided for such presentations. The consultant shall make his/her own travel arrangements in coordination with the Contracting Officer's Representative (COR). Airplane tickets must be purchased from a US carrier at the coach/economy rate. The Government shall reimburse hotel costs for up to two nights per site visit, as well as food and incidental expenses at the Government per diem rate. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer's Representative prior to being finalized or invoiced. Government Furnished Property No Government Furnished Property shall be provided. Government Furnished Information Government Furnished Information, including study data, shall be provided for the purposes of executing this requirement. Consultant(s) shall guarantee strict confidentiality of the information/data that it is provided by the NIH or by any other participant on a project to which the consultant is assigned. Confidentiality of Information Consultant(s) must guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. Confidential information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. Confidential information shall not be disclosed without the prior written consent of the individual, institution, or organization. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication. Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials. Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information. Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the Contracting Officer Representative and Contracting Officer for approval to store data longer. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause. For information to be utilized under this contract, or a portion thereof, which is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act. Information Technology (IT) Security Requirements NINDS requires that the consultant's meet certain minimum IT Security Requirements: All computers that are used by the consultant to perform work under this contract whether contractor furnished or government furnished will have to have: •Virus protection with regular automated scans •Up to date security patching •Two factor authentication •Encryption - FIPS 140-2 compliant encryption solution •Regular vulnerability scans and if the scan produces any high or medium results they need to be correction the high within 30 days and the mediums within 90 days. •Contractors will have to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/. •Consultant will have to sign the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf •Report any lost or stolen NIH data to Donna Stephenson, NINDS ISSO 301.496.0368 donna.stephenson@nih.gov within one hour (also notify the Contracting Officer Representative and Contracting Officer) of knowing of the lost or theft even if the data is on a contractor furnished computer. https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/scroster.aspx •Contractors must adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx Please refer to Appendix A for a full list of the IT security requirements. Section 508 Compliance Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies' electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board's Web site at https://www.access-board.gov/508.htm. Unless it is an "undue burden" or compliant products or services do not exist, the products must conform to Section 508. The contractor should state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception. NINDS may put contractor's presentation on its public website. Presentations (video and/or Powerpoint) must allow for individuals with disabilities to view them by following Section 508 accessibility standards from the United States Board 36 CFR Part 1194. Section 508 requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. For example, presentations should not use color coding as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element. In addition, all training and informational video and multimedia productions which support the agency's mission, regardless of format, that contain speech or other audio information necessary for the comprehension of the content, shall be open or closed captioned. Partially conforming presentations will be accepted from the contractor, since the COR will work with the contractor and the NINDS IT Web Team to make contractor's presentation fully compliant with Section 508. Data Rights The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and shall be made a part of any resulting contract/order. Non-Personal Service Statement Contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR). Contract Type The Government intends to issue one or more fixed price requirement contract(s) in reference to this requirement. Each contract shall include fixed hourly rates for each contract period. Only funding for the minimum level of effort is guaranteed, but funding may be obligated for additional hours up to the maximum level of effort specified in this solicitation. Question and Answer Period Interested contractors may submit questions relating to this requirement. Questions shall be submitted to the contract specialist, Lauren Phelps via email at lauren.phelps@nih.gov by or before 05/17/2016 at 5:00 PM EST. Late questions shall not be accepted. Questions will be anonymized and answered and the answers will be provided as soon as possible after the question deadline via solicitation amendment. Should no questions be received, no amendment shall be posted. RESPONSE FORMAT Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical proposal and 2) a separate price proposal. The technical proposal should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to forty (40) single-sided pages. The price proposal must include fixed hourly rates for proposed consultant(s) for each contract period. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." I MPORTANT NOTE TO OFFERORS: PLEASE ENSURE THAT YOUR RESPONSE MEETS THE FORMAT REQUIREMENTS AND SPECIFICALLY ADDRESSES EACH OF THE TECHNICAL EVALUATION CRITERION AND THE EVALUATION FOCUS THAT IS INDICATED FOR EACH CRITERION. PROPOSALS MUST INCLUDE BOTH A TECHNICAL DOCUMENT AND A SEPARATE PRICE PROPOSAL. CONTRACTORS NOT SUBMITTING BOTH A TECHINICAL PROPOSAL ADDRESSING THE EVALUATION CRITERIA AND A SEPARATE PRICE PROPOSAL SHALL NOT BE CONSIDERED. EVALUATION CRITERIA FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contact resulting from this solicitation on the basis of best value in consideration of trade-off between technical factors and price/cost. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows, in order of importance: Factor 1: Technical Capability (35 Points) The Contractor's proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. Ability to effectively communicate will be particularly considered. Factor 2: Key Personnel Qualifications (10 Points) Offerors proposals shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work. Offeror proposals must contain a resume/CV and indicate the following minimum qualifications: a)A minimum of an undergraduate degree in a relevant scientific discipline. b)A minimum of 10 years' experience in the biotechnology, pharmaceutical industry or regulatory industry is required. c)A minimum of 2 years hands-on and in-depth consulting experience in early nonclinical and early clinical development of biologics. This is a Pass/Fail evaluation criterion. Offerors whose proposed personnel meet all of the minimum qualifications will received the full 10 points and offerors whose proposed personnel do not meet all of the minimum qualifications will receive 0 points for this criterion. Factor 3: Past Performance The Contractor shall provide at least two (2) past performance references with knowledge of the contractor's relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information: a)Name of Organization b)Description of Contractor's responsibilities as they relate to this SOW c)Contract Period of Performance d)Contact Name and Title e)Telephone Number f)E-mail address Past Performance shall be evaluated as follows: Factor 3(a) -- Experience in Early Nonclinical Development and Approach to Providing Expert Review and Advice (35 Points) 1.Contractor's past experience in early nonclinical development of different biologics leading to successful pre-IND meeting outcomes for clients and IND submissions to FDA (CDER and CBER). Contractor is expected to integrate regulatory guidance with research plans to span all aspects of nonclinical development to secure a successful IND package for different biologics. 2.Contractor's approach to providing expert review and advice for regulatory strategy development, early nonclinical product development planning, target product profile development, risk analysis, and regulatory submission strategy for different biologics - such as peptides, antibodies, recombinant proteins, oligonucleotides, cell and gene therapies. Factor 3(b) -- Experience in Enabling Early Clinical Development and Clinical Study Design (20 Points) 1.Contractor's past experience in enabling early clinical development and clinical study design considerations for biologics. 2.Contractor experience and knowledge to provide regulatory advice for advanced and/or novel potential biologics-based therapies. Technical proposals will be evaluated using a summary adjectival rating based on total numerical score in accordance with the above and the following scale: Excellent (90 - 100) Very Good (80 - 89) Good (70 - 79) Fair (60 - 69) Poor (0-59) The Government reserves the right to make one, more than one, or zero awards in reference to this solicitation. Should multiple awards be made, they will be made on the basis of best value in consideration of both technical factors and price. Multiple awards, if made in reference to this solicitation, shall be made in accordance with available budget up to a maximum of three awards. Awards shall be made to the contractors offering the greatest value in consideration of both technical factors and price. Award shall not be considered for proposals evaluated to be "Poor." APPLICABLE CLAUSES AND PROVISIONS The FAR clauses and provisions below shall apply to this solicitation. Please note that any clauses requiring fill-ins shall be completed at time of award. 1.All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2.The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition. 3.A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4.FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (October 2015) apply to this acquisition. 5.FAR 52.216-18, Ordering (October 1995) is applicable to this acquisition. (a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from August 1, 2016 through July 31, 2021. (b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control. (c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule. 6.FAR 52.216-19, Order Limitations (October 1995) is applicable this acquisition. (a) Minimum order. Following the initial minimum order of quantity 30 Hours, when the Government requires supplies or services covered by this contract in a quantity of less than 10 Hours, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract. (b) Maximum order. The Contractor is not obligated to honor- (1) Any order for a single item in excess of 150 Hours; (2) Any order for a combination of items in excess of 180 Hours; or (3) A series of orders from the same ordering office within thirty (30) days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section. (c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section. (d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within two (2) days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source. 7.FAR 52.216-21, Requirements (October 1995) is applicable to this acquisition. (a) This is a definite-quantity, indefinite-delivery contract for the supplies or services specified, and effective for the period stated, in the Schedule. (b) The Government shall order the quantity of supplies or services specified in the Schedule, and the Contractor shall furnish them when ordered. Delivery or performance shall be at locations designated in orders issued in accordance with the Ordering clause and the Schedule. (c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations. (d) Any order issued during the effective period of this contract and not completed within that time shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after September 30, 2021. 8.FAR clause 52.217-5 Evaluation of Options (July 1990) applies to this acquisition. 9.FAR clause 52.217-9 Option to Extend the Term of the Contract (March 200) applies to this acquisition. 10.The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 11.FAR clause 52.227-14 Rights in Data-General (May 2014) is applicable to this requirement. 12.HHSAR clause 352.224-70 Privacy Act (December 18, 2015) is applicable to this requirement. 13.HHSAR clause 352.237-75 Key Personnel (December 18, 2015) is applicable to this requirement. 14.The information security clauses included in Appendix A of this solicitation are applicable to this acquisition. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." CONTRACTOR PERFORMANCE EVALUATION Final Evaluation of Contractor performance will be prepared for the resulting contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. Final evaluation 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 evaluation, 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. Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov CONTRACTING OFFICER'S REPRESENTATIVE A Contracting Officer's Representative (COR) shall be assigned to the awarded contract. 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; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract The Government may unilaterally change the COR designation for this contract. CLOSING INFORMATION Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-16-287. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.
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