SOURCES SOUGHT
A -- Division of Microbiology and Infectious Diseases: Regulatory Affairs Support
- Notice Date
- 11/7/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHS-NIH-NIAID-SBSS-14-NIHAI2014004
- Point of Contact
- Tiffany Chadwick, Phone: 3014350699, George Kennedy, Phone: 301-451-2607
- E-Mail Address
-
tiffany.chadwick@nih.gov, kennedyg@niaid.nih.gov
(tiffany.chadwick@nih.gov, kennedyg@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction THIS SMALL BUSINESS SOURCES SOUGHT NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. ALL SMALL BUSINESSES ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541711 WITH A SIZE STANDARD OF 500 EMPLOYEES. Description Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which is funded through a variety of research grants and contracts. Developing and testing new vaccines and therapies have historically been a major focus of the research supported by the DMID. Much of this research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases (e.g., avian influenza and West Nile Virus), as well as those supporting the evaluation of the safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm). In order to ensure that the development, testing and manufacture of products evaluated under DMID-supported clinical research are executed with a rigor that will support licensure by the Food and Drug Administration (FDA), DMID supports an infrastructure to provide regulatory assistance in the development and testing of these products. Currently, DMID sponsors approximately 100 Investigational New Drug Applications (INDs) or Master Files (MFs) which span more than 200 clinical trials. This includes both multicenter trials and single center studies, and encompasses Phase 1, 2, and 3 clinical trials performed at both domestic and foreign sites. DMID files approximately 10-20 new INDs each year, and in this capacity, serves as the official IND sponsor and liaisons with the FDA with respect to all regulatory requirements. Currently, the DMID IND portfolio is comprised of approximately 75% vaccine and other biologic (monoclonal) INDs, 20% drug INDs, and 5% MFs. DMID is also the sponsor of an open Investigational Device Exemption application (IDE) and supports interaction with the FDA for studies that support 501(k) filings. The purpose of this anticipated solicitation is to provide scientific, regulatory, technical, project management, and administrative assistance for a broad spectrum of DMID research activities poised for regulatory approval or licensure. Anticipated Period of Performance: It is anticipated that a single cost-reimbursement, Level of Effort type contract will be awarded with a one-year base period of performance beginning in or around July 2015 and the inclusion of 6 one-year Option Periods. The total potential period of performance, including options, is seven years. Capability Statement/Information Sought: Sources are expected to have the expertise, personnel, and facilities to meet requirements of this project. Tailored Capability Statements submitted as a result of this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following technical areas: 1.Relevant experience in the review, preparation and submission of regulatory documents to the Food and Drug Administration (FDA), including Investigational New Drug (IND), pre-IND, Investigational Device Exemptions (IDE) and pre-IDE applications. 2.Experience with both paper and electronic submissions of INDs to FDA. 3.Experience in meeting CDRH requirements for electronic copies of paper IDE submissions. 4.Ability to conduct regulatory training activities. 5.Ability and experience in providing specialized regulatory expertise, e.g., assay development and validation, and to provide and/or oversee cGCP, cGLP and cGMP document and facility audits. 6.Ability to provide, maintain and operate regulatory database information systems. 7.Ability to coordinate regulatory support functions with other clinical research support contractors. 8.Capacity and facilities to perform regulatory tasks, including writing all sections of INDs, drafting FDA briefing documents, and preparing other communications for submission to FDA. 9.Experience and capabilities to develop and maintain electronic document libraries, route documents for approval, and track regulatory due dates (i.e. annual reports). 10.Ability to provide adequate, appropriate facilities and resources dedicated to the project, including security against catastrophic loss of data. 11.Ability to provide personnel with the training, expertise, and experience necessary to accomplish the full scope of regulatory requirements for projects of similar size, scope, and complexity. How to Submit a Response: 1.Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed five pages, excluding resumes, describing the company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed; (2) demonstrated scientific and technical ability to carry out the work; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; (4) the capability to provide the required level of effort on a continuing and emerging needs basis; (4) resumes for proposed key personnel, which reflect education, and previous work relevant to the proposed requirement; (5) a general description of the facilities and other resources needed to perform the work. Tailored capability statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferable placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. If there are any responsible contractors who have proven experience and meet the capabilities cited to perform the requirement, they may submit experience, capabilities and qualifications as outlined above which will be considered by the NIH. This notice of intent is not a request for competitive proposals. However, all information received within fourteen (14) days after date of publication of this synopsis will be considered by the Government. 2.Required Business Information: •DUNS. •Company Name. •Company Address. •Company Point of Contact, Phone and Email address •Current GSA Schedules appropriate to this Sources Sought. •Do you have a Government approved accounting system? If so, please identify the agency that approved the system. •Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management ("SAM"). All offerors must register with SAM (https://www.sam.gov/). 3.Number of Copies and Delivery Point: Please submit one (1) electric copy of your response as follows: All capability Statement sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to Tiffany Chadwick, Contracting Specialist, at tiffany.chadwick@nih.gov in MS Word, WordPerfect or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID-SBSS-14-NIHAI2014004. Facsimile responses will not be accepted. 4.Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:30PM (Eastern Prevailing Time) on 11/27/2013. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. All responses must be received at NIAID by the specified due date and time in order to be considered. Facsimile responses will not be accepted. In conclusion, 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. 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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