SOURCES SOUGHT
R -- Regulatory Affairs Consulting Services for the NINDS
- Notice Date
- 3/10/2016
- Notice Type
- Sources Sought
- 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-SBSS-16-242
- Archive Date
- 4/1/2016
- 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
- Request for Information/Sources Sought HHS-NIH-NIDA-SSSA-SBSS-16-242 Regulatory Affairs Consulting Services for the NINDS Contracting Office Address: 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, MD 20892, UNITED STATES. Introduction: 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. 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 Purpose and Objectives for the Procurement: 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 awarding multiple consulting awards in reference to this requirement. Project Requirements: Biologics regulatory affairs consultant 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. Anticipated Contract Type: A requirements contract with fixed price labor rates is anticipated. The contract is expected to contain four (4) one-year option periods. Period of Performance: This requirement shall have a base period from August 1, 2016 through July 31, 2017 plus four (4) one-year option periods. Place of Performance: The contractor shall provide services remotely from its own site. Capability Statement: Contractors that believe they possess the ability to provide the required consulting support 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) documentation of ability to provide the required consulting support services, 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, 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. 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 to Lauren Phelps, Contract Specialist, via email at lauren.phelps@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 in Federal Business Opportunities. 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.
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