Inactive Total Small Business Set-Aside (FAR 19.5)

Sources Sought Notice Number: 75N95022R00024 Title: Regulatory Affairs Support Classification Code: R -- Professional, administrative, and management support services NAICS Code: 541690 - Other Scient... Sources Sought Notice Number: 75N95022R00024 Title: Regulatory Affairs Support Classification Code: R -- Professional, administrative, and management support services NAICS Code: 541690 - Other Scientific and Technical Consulting Services Response Due Date: May 19, 2022 at 5:00 pm 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, veteran owned 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: The National Institute on Drug Abuse (NIDA) is the lead Federal agency for the conduct of basic, clinical and epidemiological research to improve the understanding, treatment and prevention of drug abuse and addiction and the health consequences of these behaviors. This research is designed to increase knowledge and promote effective strategies to deal with health problems and issues associated with drug abuse and addiction. The Division of Therapeutics and Medical Consequences (DTMC) strives to accelerate the speed with which new compounds are identified, evaluated, developed and approved as new medications to treat drug abuse and addiction. Therefore, potentially useful compounds are solicited from commercial, government and academic sources. These compounds are evaluated based on their stage of preclinical and clinical development. The program seeks to develop new pharmacotherapeutic medications to treat the symptoms and disease of drug abuse, including medications to: achieve abstinence; block the effects of abused drugs; reduce the craving for abused drugs; moderate or eliminate withdrawal symptoms; block or reverse the toxic effects of abused drugs; and prevent relapse in persons detoxified from drugs of abuse. 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. This proposal is a competitive renewal of current contract No. HHSN271201700070C. Purpose and Objectives: 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. Period of Performance: The period of performance for this requirement is 5 years. The basis for establishing this period is: This is planned to be a five-year IDIQ contract, where individual tasks with varying periods of performance are within the overall contract period. Estimate of Effort: 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 to extend the period of performance 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. Options for increased quantities shall be evaluated at the time of contract award and established at the parent contract level. The established option for increased quantity will then be exercised and applied to the individual task orders. 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. Due to the uncertain nature of this requirement, the Government cannot predetermine, above a specified minimum, the precise quantities of supplies or services that the Government may vary during each contract period, and it is inadvisable for the Government to commit itself for more than a minimum quantity. Additionally, a recurring need is anticipated through this requirement. 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, 4) availability and description of facilities and equipment required to conduct this type of work, and 5) 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 non responsive. 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. PLEASE SEE ATTACHED SOURCES SOUGHT NOTICE FOR FULL DETAILS ABOUT PROJECT REQUIREMENTS.