SOURCES SOUGHT
R -- Regulatory and Support Services for Investigational New Drug Development
- Notice Date
- 5/18/2018
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIHDA201800214
- Archive Date
- 6/13/2018
- Point of Contact
- Jeffrey Schmidt, Phone: (301) 443-6677
- E-Mail Address
-
schmidtjr@mail.nih.gov
(schmidtjr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- 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: (1) the availability and capability of qualified small business 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; or small disadvantaged 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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Purpose and Objectives The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its tremendously productive pipeline and is innovative in several ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in to ultimately translate basic science into real products and services that help improve people's lives. NCATS is currently developing a novel chemical entity for the treatment of depression. The lead compound has undergone extensive preclinical toxicology, demonstrating its excellent safety profile. In addition, its excellent antidepressant efficacy has been demonstrated in several animal models of depression. In alignment with the NCATS goals to advance translational science, the advancement of the novel chemical entity to investigation new drug status, to evaluate its safety and antidepressant efficacy within man, is of great importance. A critical element of that IND advancement is the regulatory package around the Food and Drug Administration (FDA) submission. As the nation's authority regarding the development of new drugs, the FDA is tasked with ensuring the safety, to the greatest degree possible, of any new chemical entity to be tested within man. This requires exceedingly detailed, thorough, and comprehensive documentation regarding the IND to be tested. Assembling the required details requires experts within the regulatory field, as well as continuous and ongoing assessment of the safety and stability of the compound to be assessed. The objective of this contract is to provide for regulatory support services and enable the development of the lead compound for IND status and development in man. As part of the development of a novel chemical entity as an investigational new drug (IND) in man, the FDA requires a comprehensive regulatory package to support the safety for such an IND. This acquisition is meant to enable that regulatory support. Project Requirements In their Capability Statement, respondents shall address the following regulatory and CMC requirements: 1.Scientific Review a.Scientific data review involves a comprehensive review of the nonclinical and CMC data for the IND package, including Project Management. 2.Pre- Investigational New Drug meeting support a.Included within this, is project management, questions, rehearsals for the IND meeting, facilitation of the FDA meeting, FDA communication support, and minute generation. 3.IND writing, submission, and maintenance for one year after submission a.Included within this are any revisions/alterations/additions necessary during the FDA IND 30-day review period. b.Included within this are regulatory strategy services during the FDA IND 30-day review period. c.Included within this are IND maintenance, including developmental safety update reports and investigational brochures. d.Included within this are weekly teleconferences during the post IND 30-day review period. e.IND writing to include: i.Project management. ii.Investigational brochures. iii.Protocol support. iv.Introduction, overview and investigational plan. v.Assembly, formatting, publishing, and submission. 4.Safety report submissions during the phase 1 clinical trial. 5.Physician support during the phase 1 clinical trial. 6.Monthly teleconferences during the 1-year post IND submission. 7.A selection of CMC services to include: a.Stability testing of the API. b.Technical batch stability. c.Clinical batch manufacturing and testing. d.Assembly and delivery of the CMC dossier, and associated pre-IND pre-meeting support for all Chemistry, Manufacturing, or Controls issues related to the IND. e.Quality control, checking, and assembling of the IND. Other Important Considerations In their Capability Statement, respondents shall address the following considerations: 1.Contractor is to have extensive capability and experience in the submission of INDs to the United States FDA. Extensive capability and experience is defined as having more than 50 full time staff members dedicated to regulatory support, who have on average more than 3 years' experience in regulatory support. 2.Contractor is to have international experience in regulatory support in the submission of investigational new drugs, with experience in more than 10 countries. 3.Contractor should have regulatory support capability not just during IND submission, but throughout the clinical trial process. 4.Contractor should have regulatory medical writing capability, as necessary, from pre-clinical to phase 1, through phase 3. This should be demonstrated by experience. 5.Contractor is required to have experience in multiple therapeutic fields, including but not limited to CNS diseases, cardiovascular diseases, oncology, and infectious diseases. 6.In addition to regulatory support, contractor is to have the capability to perform long term API stability testing, clinical batch manufacturing, and compilation of CMC data. 7.In additional to regulatory support, contractor is to have the capability to do in-house large and small animal toxicological testing and assessment, in case the IND assessment requires additional tests. 8.If early time points for FDA require stability testing of the API are missing/erroneous, NIH cannot take responsibility, and it may incur upon the contractor to replicate early time points for stability testing. 9.Contractor is responsible for obtaining CMC and toxicological data required for FDA IND submission from current contracting organization, in a rapid and efficient manner. Anticipated Period of Performance The Government anticipates a period of performance of September 2018 - March 2021. Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED NO LATER THAN WEDNESDAY, MAY 29, 2018 to the below Contracting Office Address, Attn: Jeffrey Schmidt. Electronic capability statements will be accepted by the primary point of contact. 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 pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. 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).
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