SOURCES SOUGHT
A -- Standards Development for Regenerative Medicine Therapies - Attachment 1- Draft Statement of Work
- Notice Date
- 7/21/2017
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1186577
- Archive Date
- 8/11/2017
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Attachment 1- Draft Statement of Work MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for Standards Development for Regenerative Medicine Therapies. This is a Sources Sought Notice to determine the availability and capability of businesses capable of providing the required services. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The associated North American Industry Classification System (NAICS) Code is 541711-Research and Development in Biotechnology with a small business size standard of 1,000 employees. Background In December 2016, Congress passed and President Obama signed into law the 21st Century Cures Act (Cures Act). Title 3 Section 3036 of the Cures Act adds section 506G to the FD&C Act and directs the U.S. Food and Drug Administration (FDA), in consultation with the National Institutes of Standards and Technology (NIST) and stakeholders to "facilitate an effort to coordinate and prioritize the development of standards and consensus definition of terms, through a public process, to support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including with respect to the manufacturing processes and controls of such products." For the purposes of this requirement, regenerative medicine therapies are defined as specified in Section 3033 of the Cures Act as cell therapies, therapeutic tissue engineering products, human cell and tissue products, or combination products with any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and Title 21 of the Code of Federal Regulations, Part 1271 (21 CFR Part 1271). Standards development is an ongoing priority in CBER's efforts to promote development of regenerative medicine therapies, which are often developed for the treatment of serious or life-threatening diseases with unmet medical needs. In 2014, CBER's Office of Tissues and Advanced Therapies (OTAT; formerly the Office of Cellular, Tissue, and Gene Therapies) convened a workshop entitled "Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products" to discuss standards development activities involving regenerative medicine therapies (Ref. 1). CBER personnel serve as liaisons to key Standards Development Organization (SDO) technical committees. In addition, CBER scientists participate in various standards working groups, and in inter-laboratory/round-robin testing of standard methods under development. The scientific and manufacturing novelty of many regenerative medicine therapies present unique challenges for meeting regulatory requirements with respect to product testing, performance characteristics, testing methodologies, scientific protocols, product quality, ingredient specifications, and compliance criteria. Increased development and use of standards have the potential to transform product development, contribute to regulatory predictability, and facilitate the overall development of regenerative medicine therapies. Objective The purpose of this contract is to support standards development for regenerative medicine therapies in the U.S. As directed by Section 3036 of the Cures Act, through a public process, FDA, in consultation with NIST and stakeholders (regenerative medicine therapy manufacturers and clinical trial sponsors, contract manufacturers, academic institutions, practicing clinicians, regenerative medicine therapy industry organizations, and standard setting organizations), will facilitate an effort to coordinate and prioritize the development of standards, and the development of a consensus definition of terms, for regenerative medicine therapies. See Attachment 1, Draft Statement of Work (SOW). Place of Performance: Contractor's facility The respondent to this source sought shall furnish sufficient information outlining their capabilities as relevant to the performance of this requirement. Though the target audience is small businesses all interested parties may respond. Responses are limited to twenty (10) pages on 8.5x11 inch paper with margins no less than one-inch on each border, single-spaced using a minimum of 12-point font size and shall number each page consecutively. A cover page and table of contents are not included in the 10 page limit. At a minimum, responses shall include the following: 1. Provide a brief corporate profile of your company to include the following: Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. 2. A detailed description of your organization's experience and demonstrated abilities to provide the required services identified in the SOW. Specific services experience in the development of standards, and the development of a consensus definition of terms, for regenerative medicine therapies. The contractor must possess available and experienced personnel. 3. Provide three (3) years of past performance information in which the offeror has provided the same or substantially similar service solutions. For each past performance reference include the date of award, description, dollar value, client name, client address, client point of contact name, client point of contact phone number, and client point of contact email address. Include role in past experience (prime or subcontractor). 4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. 5. If a large business, identify the subcontracting opportunities that would exist for small business concerns. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the SOW. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalized the SOW in preparation for the forthcoming solicitation. Interested parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 27, 12:00 PM (Central Time in Jefferson, Arkansas) at the FDA/OO/OFBA/OAGS/DAP, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1186577. 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). Attachment: Draft Statement of Work
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