eCTD Regulatory Publishing Services
MARKET SURVEY REQUEST:
THIS IS A REQUEST FOR INFORMATION ONLY for market research and planning purposes only, as defined in FAR 15.201(e). This is not a solicitation or request for competitive proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this Notice. 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, and the Government will not reimburse respondents for preparation of the response. Response to this Notice is strictly voluntary and will not affect future ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement.
Dynport Vaccine Company (DVC), through the U.S. Army Contracting Command - Aberdeen Proving Ground (ACC-APG), Natick Contracting Division, is conducting market research to obtain information regarding eCTD regulatory publishing services.
THIS IS A SMALL BUSINESS SOURCES SOUGHT NOTICE.
SPECIFICATIONS:
The objective of this notice is to seek expert eCTD publishing services to support the preparation and submission of eCTD regulatory documentation for a drug master file, investigational new drug application and a biologics license application and subsequent Life Cycle Management sequence submissions. We are seeking eCTD publishing vendors to perform document and submission level processing and submission of eCTD regulatory documentation to the Food and Drug Administration.
SUBMITTALS:
Interested parties shall respond by specifying if they have the current capabilities as listed above.
Interested Parties shall submit a short summary (no more than 5 pages total) describing their capabilities to provide these services. Interested Parties shall provide business size status based upon NAICS code 541712, Small Business Size Standard of 1,000 employees, CAGE CODE as registered at SAM.gov. Interested Parties may include brochure information with the summary package by the Government's requested date of submittal of March 2nd, 2017. Interested parties shall submit information in response to this RFI to: Linda.Howell@csra.com or by paper copy to: Linda Howell, Subcontracts Advisor, Dynport Vaccine Company LLC, a CSRA company, 64 Thomas Johnson Drive, Suite 100, Frederick, MD 21702.
Responses shall be submitted and received via Email no later than 2:00PM EST March 2nd, 2017. Documents shall be electronic in Microsoft Word, Excel, Power Point, and/or Adobe Portable Document Format (PDF) and provided as attachments to the Email. No telephonic responses to this RFI will be considered. Questions concerning this RFI may be addressed by contacting: Linda.Howell@csra.com
All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers for contract and will not be used by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Vendors having services that they believe would be suitable as described herein shall submit all supporting documentation requested by this RFI to the POC noted above.
Please provide information on your organization in the following areas;
1. Company Name, Address and Single Point of Contact (Both Technical and Administrative/Business) with Name, Title, Telephone/Fax Numbers and E-mail Address.
2. DUNS Number and Cage Code
3. Confirmation of Current Active Registration in the System for Award Management (SAM)
4. Primary NAICS Code(s) and Business Size (i.e., Small/Large...etc.)
5. GSA Schedule, If Available
Should DVC elect to pursue discussions, a Non-Disclosure Agreement will be provided for execution.
Disclaimer: This notice does not obligate DVC to solicit, award a contract or otherwise pay for the information provided in any response. DVC will not entertain questions regarding this Market Research; however, general questions regarding requested capabilities can be presented in your response.
Confidentiality: No proprietary, classified, confidential or sensitive information should be included in your response.
PROVISIONS AND CLAUSES:
52.215-3 -- Request for Information or Solicitation for Planning Purposes.
Request for Information or Solicitation for Planning Purposes (Oct 1997)
(a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation.
(b) Although "proposal" and "Offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal.
(c) This solicitation is issued for the purpose of: Market Research and Planning Purposes Only.
(End of Provision)
JENNIFER S. BASSETT, Phone 3016198401, Email JENNIFER.S.BASSETT.CIV@MAIL.MIL
