Inactive Total Small Business Set-Aside (FAR 19.5)

Title: Research Data Review and Publication Support for NIDA IRP i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart12.6 as supplemented ... Title: Research Data Review and Publication Support for NIDA IRP i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a separate written solicitation will not be issued. ii. The solicitation number is 75N95020Q00057 and the solicitation is issued as a Request for Quotation (RFQ) as 100% set-aside for small businesses. iii. 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— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. A firm-fixed price of purchase order is contemplated for this requirement. iv. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-04 / 01/15/20 v. The North American Industry Classification System (NAICS) code for this procurement is 541990 — All Other Professional, Scientific, and Technical Services with size standard of $15 million. vi. Project Requirements: Please see the attached Statement of Work for further details regarding project requirements. Contracting Officer’s Representative: The Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract and will be specified at 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 Government may unilaterally change the COR designation at any time throughout the performance period of this contract. APPLICABLE CLAUSES AND PROVISIONS vii. The provision at FAR Clause 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment is applicable to this solicitation. Offerors MUST include a completed copy of this provision with their offer, OR provide a copy of the valid certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet. See attachment. viii. The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Items is applicable to this solicitation. ix. The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition. The following is provided as an addendum to clause 52.212-2: Selection of an offeror for contract award will be based on an evaluation of proposals against the technical capability, corporate experience and price factors. Technical capability shall be considered more important than corporate experience. The sum of non-price evaluation considerations shall be considered more important than price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government. Factor 1: Technical Capability The Offeror shall detail its technical capability to perform the required tasks identified in this statement of work. Technical capability must document the Contractor’s ability to provide the support detailed in this statement of work, specifically to ensure the publication of the scientific work of postdoctoral scientists in DDSS in the proper scientific journals, to acquaint interested postdoctoral scientists with the manuscript submission process, to obtain the needed scientific experimental information from postdoctoral scientists when requested by the Chief (DDSS) and to correct it in accord with the requirements of the chosen journal, to explain, if needed or requested by the Chief (DDSS) the background and rationale for the scientific work in DDSS, to provide input on the pharmacological evaluation of compounds from DDSS scientists, to integrate the obtained pharmacological data in manuscripts, to aid interested postdoctoral scientists in their oral presentation of their scientific work, to interact with the Chief (DDSS) in discussions about the progress of the research of postdoctoral scientists in DDSS and about their future research, and detail the Contractor employee’s knowledge of the Freedom of Information Act and Federal regulations relevant to privacy and scientific research (i.e., Privacy Act, HIPPA, etc.) shall also be evaluated. Factor 2: Corporate Experience The offeror shall provide a list of two (2) contracts or purchase orders completed during the past ten (10) years, similar in size and scope to the requirements outlined in the Statement of Work. Offerors shall include the following information for each contract or purchase order listed: • Name of Contracting Organization • Contract Number • Contract Type • Total Contract Value • Description of Requirement and Specific Responsibilities of the Offeror as they relate to this SOW • Contract Period of Performance. Factor 3: Price and Options The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). x. The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition. xi. The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition. xii. The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition. See attachment. xiii. The provision of FAR Clause 52.227-14, Rights in Data – General, applies to this acquisition. xiv. The provision of HHSAR Clause 352.231-70, Salary Rate Limitation, applies to this acquisition. xv. The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices: FAR Clause 52.217-5 Evaluation of Options. FAR Clause 52.217-8 Option to Extend Services. 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 15 days. FAR Clause 52.217-9, Option to Extend the Term of the Contract. a. The Government may extend the term of this contract by written notice to the Contractor prior to contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 5 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 5 years. KEY PERSONNEL, HHSAR 352.237-75 (December 2015) 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 (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days 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 following individual(s) is/are considered to be essential to the work being performed hereunder: Name Title TBD PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE Contractor Performance Evaluations Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 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) will be prepared Annually following the anniversary date of contract award, if options are exercised. Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted fourteen 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. Electronic Access to Contractor Performance Evaluations Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading. PRIVACY ACT, HHSAR 352.224-70 (December 2015) This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term "system of records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in CFR 45 part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance. INFORMATION AND PHYSICAL ACCESS SECURITY PROVISIONS Information Security Categorization- In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Contractor Non-Disclosure Agreement and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following: Confidentiality: [X] Low [ ] Moderate [ ] High Integrity: [X] Low [ ] Moderate [ ] High Availability: [X] Low [ ] Moderate [ ] High Overall Risk Level: [X] Low [ ] Moderate [ ] High Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves: [X] No PII [ ] Yes PII Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, "PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother's maiden name, biometric records, etc. PII Confidentiality Impact Level has been determined to be: [X] Low [ ] Moderate [ ] High POSITION SENSITIVITY DESIGNATIONS All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: [ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI). [ ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI). [ X ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI). INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY A. Baseline Security Requirements 1. Applicability- The requirements herein apply whether the entire contract or order (hereafter "contract"), or portion thereof, includes either or both of the following: a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information. b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor)will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources. 2. Safeguarding Information and Information Systems- In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall: a. Protect government information and information systems in order to ensure: • Confidentiality , which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information; • Integrity , which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and • Availability , which means ensuring timely and reliable access to and use of information. b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less , bring the situation to the attention of the other party. c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov . d. Comply with the Privacy Act requirements. Protection of Sensitive Information- For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution. Confidentiality and Nondisclosure of Information - Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein. The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations: a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records); b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act). Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the "Commitment to Protect Non-Public Information - Contractor Employee Agreement" located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf . A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition. Contractor Non-Disclosure Agreement (NDA) - Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition. TRAINING 1. Mandatory Training for All Contractor Staff- All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management training course at http://irtsectraining.nih.gov/ before performing any work under this contract. Thereafter, the employees shall complete NIH Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies. 2. Role-based Training- All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum. Read further guidance about the NIH Role-based Training https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx 3. Training Records- The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request. RULES OF BEHAVIOR 1. The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and comply with the NIH Information Technology General Rules of Behavior https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx , which are contained in the NIH Information Security Awareness Training Course http://irtsectraining.nih.gov 2. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual NIH Information Security Awareness Training. If the training is provided by the contractor, the signed Rules of Behavior must be provided as a separate deliverable to the CO and/or COR per defined timelines above. INCIDENT RESPONSE The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/NIH IRT teams within 24 hours, whether the response is positive or negative. FISMA defines an incident as "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cyber security and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on. A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as "a suspected or confirmed incident involving PII" . In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall: 1. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption. 2. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send NIH approved notifications to affected individuals individuals in accordance with https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/ir_guidelines.aspx 3. Report all suspected and confirmed information security and privacy incidents and breaches to the NIH Incident Response Team (IRT) via email at IRT@mail.nih.gov , COR, CO, the NIH Office of the SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable NIH and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall: a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach; b. not include any sensitive information in the subject or body of any reporting e-mail; and c. encrypt sensitive information in attachments to email, media, etc. 4. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information HHS and NIH incident response policies when handling PII breaches. 5. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation within an hour of discovery. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12 The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2. For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12) Roster- d. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx . e. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification. f. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification. g. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations. h. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed. i. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval. j. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s). k. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3). l. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee. m. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee. xvi. The De...

Inactive

Introduction: This is a Sources Sought notice. THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS. This notice is for information and planning purposes only and does not commit the Governme... Introduction: This is a Sources Sought notice. THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. The purpose of this notice is to obtain information regarding; (1) the availability and capability of qualified sources, (2) whether they are small businesses; HUBZone small businesses, service-disabled, veteranowned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; small disadvantaged businesses; or other-than-small businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set aside is possible. Background: A major research direction of the Drug Design and Synthesis Section (DDSS), in the Molecular Targets and Medications Discovery Branch (MTMDB) of the Intramural Research Program of the National Institute on Drug Abuse (NIDA), is the elucidation of the structure and function of neurotransmitter systems in the mammalian central nervous system (CNS) and the molecular mechanism of action of CNS active drugs. Organic/medicinal chemistry is the foundation of the multidisciplinary antagonists, imaging agents, affinity ligands, and other drugs for specific applications. New, highly selective ligands for drug receptors are synthesized, using all of the contemporary tools of medicinal chemistry. DDSS is involved with research on: (1) central opioid receptor subtypes and peripheral opioid receptors, (2) narcotic tolerance and dependence, (3) the synthesis of haptens for a heroin and a fentanyl vaccine, 4) compounds that are almost or completely biased towards the G-protein-coupled receptor and that do not recruit beta-arrestin, 5) compounds that are capable of interacting with both mu- and delta-opioid receptors as potent full agonists that do not cause respiratory depression. Potent and selective ligands are prepared for specific opioid receptors. DDSS has provided tools for PET imaging of opioid receptors, purified the delta opioid receptor to homogeneity seven years prior to cloning, introduced corticotropin releasing hormone antagonists for study of stress-induced relapse to drug abuse and developed the NIH Opiate Total Synthesis. The latter renders the natural opiate enantiomers available independent of the opium poppy and thus offers poppy eradication a strategy to combat heroin abuse. It also provides unnatural opiates as valuable research tools and as potential agents for the treatment of drug abuse via functional antagonism of Toll-like 4 receptors. DDSS, MTMDB, is unique in its ability to forge ahead on these difficult and extremely important areas of science. It is essential that the research findings of DDSS, MTMDB, be made available to the scientific community by publication in highly rated journals. Purpose and Objectives: It is essential that the research findings of DDSS, MTMDB, be made available to the scientific community by publication in highly rated journals or through patents. DDSS, MTMDB, has determined that it is cost efficient and in the best interests of the Government to have a contractor perform this service, as well as a consultative service for advice on publication, rather than employing a full–time permanent employee to write publications. The contractor must have current and working knowledge of the science involved with drug-abuse research, especially in the areas of medicinal chemistry and pharmacology. He/she must be conversant with the literature in the field and have decades of experience in writing manuscripts for publication in major, highly rated, refereed journals, and able to consult with the Chief, DDSS, MTMDB, about current and future research topics that will be published. Further, the contractor must have knowledge of organic chemistry, the major spectroscopic techniques used in the field, such as nuclear magnetic resonance spectroscopy, infrared spectroscopy and mass spectrometry. He/she must be able to interpret the spectra obtained from these techniques, must be able to determine the accuracy of calculated empirical analyses, must be conversant with x-ray crystallographic determinations, and must be knowledgeable about the in vivo and in vitro techniques used in pharmacological analyses of the evaluated compounds (such as antinociceptive assays – tail flick, phenylquinone, hot plate, tail flick antagonism of morphine, AD50 assays for determination of agonist behavior at individual receptor sites, single dose suppression assays, precipitated withdrawal, dependence potential and abuse liability determinations in animals, receptor binding techniques, GTPgammaS assays, and numerous other techniques that are included in publications in, for example, the Journal of Medicinal Chemistry, Tetrahedron, Organic Letters, Journal of Organic Chemistry, Tetrahedron Letters, Bioorganic and Medicinal Chemistry, and Organic and Biomolecular Chemistry. The DDDS requires contractor support to ensure that scientific data obtained in the Section is published in refereed journals and to acquaint interested DDSS postdoctoral scientists about the publication process. Support is also required for consultation to ensure that current and future research projects suitable for publication will be carried out. Training and support will be provided by the contractor to help the postdoctoral fellow - the DDSS Visiting Fellows and IRTAs, mostly organic chemists (some of whom may not have English as their primary language), become more familiar with the writing of manuscripts in various scientific journals, and with the background of the research. The contractor will also aid with the presentation of posters and oral reports by postdoctoral fellows and will be available for consultation both onsite and/or through a home office via phone or email. Project Requirements: The Contractor must be expert in the fields of organic and medicinal chemistry, spectroscopy, and pharmacology as they relate to the scientific areas of importance to DDSS, and is required to have the experience, knowledge and ability to accomplish the following: 1) Dissemination of DDS work: the contractor will assist the Chief (DDSS, NIDA) to collect, review, and select DDSS research data to publish in first-rate, refereed scientific journals. The number of manuscripts is variable and is dependent on the number and the output of the postdoctoral fellows. During the past several years, the Chief (DDSS, NIDA) has been a co-author on about 100 publications. The contractor will also aid with the presentation of posters and oral reports by postdoctoral fellows and will be available for consultation both onsite and/or through a home office via phone or email. A) Manuscript preparation: The contractor shall write, and train interested postdoctoral fellows to write, manuscripts for publication. This will include the introduction, results and discussion, and conclusion, compile the references and the acknowledgement sections of the manuscript, as well as gather material (e.g. CCDC numbers when necessary for publication), for all DDSS manuscripts. The postdoctoral fellows in DDSS will provide written experimental work needed for the manuscript. i. The Contractor will create manuscripts including both text and visual elements using Microsoft Word, ChemDraw, Endnote, etc. The work must be compatible with the Apple operating system for Mac computers. ii. The Contractor will modify the written experimental work provided by DDSS postdoctoral fellows for compliance with the journal’s requirements, will examine the experimental work to assure that it is complete and sufficient for publication, and will request additional information from these scientists when the Contractor or Chief (DDSS, NIDA) deems it necessary. iii. The Contractor will ensure that all manuscripts are written in accordance with the requirements of the journals in which they shall be published, and proof-read all manuscripts for spelling, grammar, and nomenclature. The journal will be chosen by joint agreement of the Chief (DDSS, NIDA), the author (s), the DDSS postdoctoral fellows involved, and the Contractor. These journals include, but are not limited to, Journal of Medicinal Chemistry, European Journal of Medicinal Chemistry, Journal of Organic Chemistry, Chirality, Bioorganic and Medicinal Chemistry, Organic Letters, Science, Helvetica, Tetrahedron, Organic and Biomolecular Chemistry, Heterocycles, Journal of Heterocyclic Chemistry, Synthesis, Journal of Labelled Compounds and Radiopharmaceuticals, Journal of Natural Products, Tetrahedron Letters. B) Manuscript submission: i. The Contractor will assist postdoctoral fellows in the preparation of finalized manuscripts for journal submission. Manuscript articles are generally submitted online and submission cover letters drafted for approval by the Chief (DDSS, NIDA). The Contractor will submit manuscripts to journals for the Chief (DDSS, NIDA), and will teach interested postdoctoral fellows how publication is accomplished. ii. The Contractor shall make as many unbound copies of the printed manuscript as needed (at this time one copy is needed), prior to submission to the journal and send the copy through the proper channels to the Chief of the Branch, for the Office of the Intramural Scientific Director, for approval. The Contractor shall also provide a copy of each submitted manuscript to each author, either by email or in printed form, as desired by the authors. iii. The Contractor will ensure that all paperwork necessary to establish the manuscript as work of the US Government is completed. Generally, this includes the NIH Publishing Agreement which will be filled out and provided to the Chief (DDSS, NIDA) or to the Chief of the Branch for signature, and sent by the Contractor to the journal, generally via an online site, or by whatever other means is deemed necessary. C) Manuscript revision: i. Following journal review, the Contractor will assist postdoctoral fellows in the manuscript revision process, and provide answers, if needed, to any comments or questions from journal reviewers and via editorial review. The Contractor may contact the manuscript author(s) as necessary for assistance, and the Contractor will compile the information required for any needed revision. ii. The Contractor will resubmit the revised manuscript, generally using the online site of the journal. Upon resubmission, the Contractor shall write and include a letter for the Chief (DDSS, NIDA) to the journal editor explaining all revisions made to the manuscript. This entire process will also be used as a teaching tool for interested DDSS postdoctoral fellows who wish to become involved in the process. D) Manuscript Distribution: i. Following manuscript acceptance and publication, the Contractor will ensure that the manuscript is forwarded to PubMed Central for publication in PubMed. The Contractor will be responsible for any manuscript changes needed for PubMed publication and will contact the authors as necessary for this purpose. 2) Posters and oral presentations A) Posters from postdoctoral fellows will be examined, corrected, and input will be provided, when necessary. B) Oral presentations of postdoctoral fellows will be aided, and input will be provided, when necessary, especially for DDSS postdoctoral scientists for whom English is not their primary language. 3) Current and working knowledge of the science involved with drug-abuse research, especially in the areas of medicinal chemistry, organic chemistry, and pharmacology. A) Current knowledge of the literature in the field, and considerable experience in writing manuscripts for publication in major, highly rated, refereed journals, B) The ability to discuss with the Chief, (DDSS, NIDA), possible current and future research topics that will have the potential for publication, and the ability to discuss with DDSS postdoctoral scientists the background and rationale for their work and prepare them, if needed, to present their work to audiences at national and international scientific conferences and aid in their preparation of seminars/lectures for employment after they leave DDSS, NIDA. C) Knowledge of the major spectroscopic techniques used in the field, such as nuclear magnetic resonance spectroscopy, infrared spectroscopy and mass spectrometry. D) The Contractor must be able to interpret the spectra obtained from various techniques, must be able to determine the accuracy of calculated empirical analyses, must be conversant with x-ray crystallographic determinations. E) The Contractor must be knowledgeable about the in vitro (binding assays and 35S-GTP?S assays) and in vivo techniques used in pharmacological analyses of evaluated compounds (such as antinociceptive assays – tail flick, phenylquinone, hot plate, tail flick antagonism of morphine, AD50 assays for determination of agonist behavior at individual receptor sites, single dose suppression assays, precipitated withdrawal, dependence potential and abuse liability determinations in animals, and numerous other techniques that are included in DDSS publications. Contractor must have extensive knowledge of the structure-activity relationships of the opioids, cannabinoids, psychomotor stimulants, and other classes of drugs of abuse. Period of Performance: This purchase order shall have a base period of performance of twelve months. The purchase order shall also contain four (4) twelve-month option periods. Option periods may or may not be exercised at the unilateral discretion of the Government. Should all option periods be exercised, the purchase order will have a total duration of five years. Estimate of Effort: The estimate of effort is one (1) part-time individual at 20 hours per week. Capability Statement: Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the above outlined requirements, 3) an outline of previous scientific research writing activities in which the contractor has participated, and 4) any other information considered relevant to this program. Contractors must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Contractors also should provide a list of IDIQ or GWAC contracts currently maintained that may be of relevance to this potential requirement. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered nonresponsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Alexander Beraud, Contract Specialist, at Alexander.Beraud@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published on https://beta.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a firm fixed price contract. Place of Performance: Services shall generally be performed onsite by the Contractor, and the Government will provide the necessary resources and space. Sufficient equipment (e.g. laptop computer) will be loaned to the Contractor to enable home-based work whenever necessary, and to answer necessary questions whenever they are requested by the Chief (DDSS, NIDA), or DDSS postdoctoral scientists. The Contractor is expected to meet with DDSS scientists at the DDSS site formally or informally as necessary. A total of 3 or more on-site meetings per week for an anticipated onsite duration of 20 hours/week, and when deemed necessary by the Chief (DDSS, NIDA), the Contractor may use a home office offsite to complete manuscripts, or answer the questions of DDSS postdoctoral scientists relating to the scientific work of DDSS. The DBSS site is located in Rockville, Maryland 20850. Primary Point of Contact: Alexander Beraud, Contract Specialist Alexander.Beraud@nih.gov Phone: 301.827.6857 Secondary Point of Contact: Andrew Hotaling, Contracting Officer Andrew.Hotaling@nih.gov Phone: 301.443.6677