Inactive

The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N95023R00009 for "Regulatory Affairs Support". This Request for Proposal is prepa... The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N95023R00009 for "Regulatory Affairs Support". This Request for Proposal is prepared in accordance with the Uniform Contract Format prescribed for Government Wide application by the Federal Acquisition Regulation (FAR). The Uniform Contract Format is both a Request for Proposal and a contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format. We expect to award an indefinite delivery, indefinite quantity (IDIQ) contract with cost reimbursement type (completion or term form) task orders. NIDA anticipates the IDIQ contract will have an ordering period of five years and will include a guaranteed minimum of $1,000 and a maximum value of $2,400,000 for the ordering period. Task orders may include, options for increased quantities and options to extend the period of performance. Future year funding will be dependent on programmatic needs and funding availability. The Government anticipates an award will be made on or around September 20, 2023. Interested parties should respond with technical and business proposals for the entire project. Please include separate cost proposal for each individual task order and option proposed. THIS IS A 100 PERCENT SET-ASIDE FOR SMALL BUSINESS. Proposals received from firms that are not small business concerns, as defined by the North American Industry Classification System (NAICS) code, are not eligible for award. The NAICS code applicable to this buy is 541690. See Section L.1.c. of this RFP. In addition, FAR Clause 52.219-14 ‘Limitation on Subcontracting’ is applicable under this solicitation, and this clause requires that at least fifty (50) percent of the cost of contract performance incurred for personnel be expended by employees of the small business firm. General Particularly direct your attention to Part IV, which contains instructions, provisions, and evaluation factors for the submission and review of proposals. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Review these parts as to the effects on performance capability and technical and cost considerations in the development of your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III which otherwise appear to require the insertion of data. The Government will complete those Parts prior to contract award and (if negotiations are conducted) will tailor those items through final negotiations. All offerors must be REGISTERED and have an ACTIVE System for Award Management (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management (www.sam.gov) must be in full compliance with FAR 52.204-7 System for Award Management and FAR 52.204-13 System for Award Management Maintenance to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirements. You must have an authorized organizational official sign your Business Proposal. It must contain a detailed breakdown of costs by year and individual options, for each cost category/element, an explanation of the basis for all costs, and provide documentation to support these costs. We direct special attention to the Breakdown of Proposed Estimated Costs (plus fixed fee) w/Excel Spreadsheet contained in the Business Proposal Cost Information, Attachment 08. Please provide an electronic copy of the spreadsheet in this format. Do not send encrypted files. Use of the above format will hasten review and award. See Section L.2.c. Business Proposal Instructions for additional detail. Please include a completed Form NIH-2043, “Proposal Summary and Data Record” with the Business Proposal. Note that in addition to telephone and fax numbers, you should include the email addresses of both the Principal Investigator and the responsible business representative on the form. Format and content requirements of your Technical Proposal are detailed in Section L.2.b. Technical Proposal. Also, you should complete the “Technical Proposal Cover Sheet” and use it as the cover sheet for each copy of your technical proposal. It is important that you list all professional personnel and organizations named in the proposal who have any role in the proposed work. This includes your staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. You may use extra sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. We will use this information to ensure that no conflicts of interest exist with the selected review committee members. The Offeror must submit its Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal. If you want to receive an e-mail notice of any amendments to this RFP, you should register on the SAM.gov website. Also, NIDA wil post all amendments, or provide an appropriate link, on the SAM.gov website. Offeror Questions and Intent Requests for clarification, additional information, or correction must be made in writing to the Contract Specialist and Contracting Officer. A completed "Proposal Intent Response Sheet." Attachment 02 of the RFP: Please complete this form and return it to this office on or before April 17, 2023 at 3:00 P.M. Eastern Time. Questions should be submitted by e-mail to alex.beraud@nih.gov and josh.lazarus@nih.gov with the subject line: “Questions – 75N95023R00009”. The Completed Proposal Intent Response Sheet, should be submitted on or before 3:00 P.M. Eastern Time on April 28, 2023. The response sheet should be submitted by e-mail to alex.beraud@nih.gov and josh.lazarus@nih.gov with the subject line: “Offeror Intent – 75N95023R00009". Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) and no later than 3:00 p.m., Eastern Standard Time (EST) on May 05, 2023. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal. Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit may take up to three (3) business days. Please plan accordingly. Additional instructions on submitting a proposal via eCPS can be found at https://ecps.nih.gov/howtosubmit and in Attachment 1. All notices related to this solicitation will be posted on SAM (https://www.sam.gov). In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary. Disclaimers This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition. Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984). Requests for any information concerning this RFP should be directed to Alexander Beraud, NIDA Office of Acquisitions, Red Branch, who may be reached at alexander.beraud@nih.gov; collect calls will not be accepted. Discussions with any other individual outside the NIDA Contracts Management Branch should not occur. PLEASE SEE THE ATTACHED REQUEST FOR PROPOSAL FOR ALL RELEVANT DETAILS AMENDMENT 01 ADDED 04/26 ANSWERING SUBMITTED QUESTIONS - PLEASE REVIEW FOR ALL RELEVANT DETAILS

Inactive Total Small Business Set-Aside (FAR 19.5)

A. Objectives: The National Institute on Drug Addiction (NIDA), Division of Therapeutics and Medical Consequences (DTMC), intends to solicit proposals using competitive procedures as a SMALL BUSINESS ... A. Objectives: The National Institute on Drug Addiction (NIDA), Division of Therapeutics and Medical Consequences (DTMC), intends to solicit proposals using competitive procedures as a SMALL BUSINESS SET-ASIDE from qualified and capable Small Businesses certified under NAICS Code 541690; to support the regulatory needs generated by NIDA supported studies. The purpose of this contract is to provide resources to support the regulatory needs generated by NIDA supported studies. NIDA reserves the right to have the contracted services provided to benefit NIDA or any other component of the NIH. This contract will provide such support by preparing regulatory submissions for filing with the Food and Drug Administration (FDA). These submissions will consist of Initial Investigational New Drug (IND) applications, New Drug Application (NDA) and supplemental NDA (sNDA) submissions, annual reports, protocol amendments, information amendments, and Ad Hoc documents. The vendor will ensure that the regulatory submissions are in accordance with FDA regulations, International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP) guidelines. B. General Requirements: Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the following tasks on preparing regulatory submissions for filing with the Food and Drug Administration (FDA). IND Application Preparation and Submission IND Annual Report Preparation IND Annual Report Preparation (simplified version) IND Protocol Amendment Preparation IND Information Amendment Preparation Investigator’s Brochure Updates NDA Preparation and Submission sNDA Preparation and Submission Ad Hoc Regulatory Support Functions D. Additional Information: NIDA anticipates that one single-award IDIQ contract will be awarded with an ordering period of five (5) years. NIDA anticipates the award of cost-plus fixed fee task orders under this contract. These individual task orders may include options to extend the period of performance and/or options for increased quantities. If options and option quantities are utilized for an individual task order, then they will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. NIDA anticipates that at least one task order will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds. Various task orders will be issued to support distinct tasks and deliverables in accordance with the Statement of Work. RFP No. 75N95023R00009 will be available electronically on or about February 15, 2023. You can access the RFP through SAM.gov. All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due approximately 30 days from the release date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. This advertisement does not commit the Government to award a contract. PLEASE SEE ATTACHED SYNOPSIS FOR ALL RELEVANT DETAILS

Inactive Total Small Business Set-Aside (FAR 19.5)

Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding ... Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified small business sources to perform a potential R&D requirement. This notice is issued to help determine the availability of qualified small business sources technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The mission of the National Institute of Neurological Disorders and Stroke (NINDS) is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. Purpose/Objective: The NINDS is interested in identifying organizations with requisite qualifications and capabilities to provide a full service, turn-key Phase I Clinical Trials Facility in support of the development of novel neurotherapeutic agents. This full-service facility is to perform a full range of services from protocol development through submission of final clinical study reports to be used by the NINDS and sponsored Investigators/Collaborators. The emphasis of this Phase I Clinical Trials Facility will be to perform Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Phase I clinical trials utilizing NINDS-supplied novel agents developed by NINDS, sponsored Investigators or Contributors with an emphasis on first in human testing to determine the tolerated dose range, the dosing regimen, the safety profile and pharmacokinetic (PK) parameters. Assigned Phase I Clinical Trials may also include pharmacodynamics (PD), and evaluation of biological effects and early signs of efficacy. The data generated from these trials will be used by the NINDS and sponsored Investigators/Collaborators and ultimately serve as the basis to advance candidate compounds for further clinical development if appropriate. It is anticipated that up to three to five Phase I Clinical Trials will be performed per year for the duration of the contract, and that multiple Phase I Clinical Trials will likely need to be conducted concurrently at the Phase I Clinical Trials Facility. Project Requirements: Organizations who believe that they have the experience and possess the requisite qualifications and capabilities to provide a full service, turn-key Phase 1 Clinical Trial Facility, are asked to address each of the following capabilities in their response. Ownership/control of a clinical trial facility with capabilities for housing research subjects and performing Phase 1 clinical trials; Immediate access to supportive care in the event of a serious adverse event; Experience conducting both first in human SAD and MAD Phase I studies, in healthy volunteers in compliance with NIH and FDA regulations and ICH GCP guidelines; Capacity to perform multiple Phase 1 SAD and/or MAD clinical trials concurrently per year; Ability to perform timed sample collection including blood, urine, CSF and other bodily fluids/tissues; Ability to recruit and retain the trial subjects; access to neurology patients if required via existing relationships; Established relationships and/or in-house capabilities to provide specialized imaging for assessment and/or performing specific safety evaluations, e.g. CT, MRI, PET, EMG, EEG and ERG; Availability of an onsite investigational pharmacy including drug storage facility and limited cGMP capability for compounding and manipulations. Have current accreditation and certification for the performance of pharmacy services; Ability to work with a range of investigational products such as small molecule and/or peptide and/or antibody and/or protein products; Availability of a certified laboratory for conducting hematology, chemistry and sample testing including on-site specimen storage facility at room temperature, 4, -20 and -70 degrees Celsius; Ability to do bioanalysis including but not limited to PK, anti-drug antibody testing, and biomarker measurements; Established relationships and/or in-house capabilities to do exploratory efficacy measurements for a variety of neurological outcomes; Established quality control and assurance procedures; Ability to develop and maintain clinical trial databases; Experience, expertise, and availability of in-house and/or on-staff personnel necessary to perform inpatient Phase 1 clinical trials, including first in man trials, to include, but not limited to: Project managers Licensed physicians Research nurses Clinical pharmacologist with expertise in analysis and reporting of PK and pharmacodynamics (PD) data from Phase 1 clinical trials Medical specialists to perform safety assessments (e.g., ophthalmologists or neurologists) and PD measures Study coordinators and clinical research assistants/associates Pharmacovigilance Protocol development and oversight Data management/IT resources Statistical analyses Medical writing Suitable regulatory affairs including preparing submissions to the FDA Technical and administrative management infrastructure to ensure the efficient planning, implementation, communication, oversight and completion of all clinical operation services Capability statement /information sought. Respondents must provide clear and convincing documentation of their capability of providing the required services specified in this notice. Respondents must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. Respondents must submit their response in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. Responses are limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if requested. Responses must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses must be submitted to Evan Feely, Contract Specialist, via e-mail at evan.feely@nih.gov. Facsimile responses are NOT accepted. All responses must be received on or before the closing date of this notice and reference notice number: 75N95023R00009. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in 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 a review of the responses received, a presolicitation synopsis and solicitation may be published in SAM. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”