SPECIAL NOTICE
A -- Request for Information (RFI)--Good Manufacturing Practice (GMP) Storage and Good Laboratory Practice (GLP) Archiving
- Notice Date
- 7/28/2015
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH15RFI
- Archive Date
- 7/27/2016
- Point of Contact
- TOLORIA DUVALL, 3016192836
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(toloria.s.duvall.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Agency: U.S. Army Medical Materiel Development Activity (USAMMDA) Office: Division of Regulated Activities and Compliance (DRAC) Location: Fort Detrick, MD 21702 Summary: In accordance with Federal Acquisition Regulation (FAR) 15.201 quote mark Exchanges With Industry Before Receipt of Proposals quote mark and FAR 52.215-3, quote mark Request for Information or Solicitation for Planning Purposes quote mark this Request for Information (RFI) is for information and planning purposes only at this time and shall not be construed as a solicitation or as an obligation on the part of USAMMDA or DRAC. This RFI is not expected to be a Request for Proposal (RFP) or Invitation for Bid (IFB), nor does it restrict the Government to an ultimate acquisition approach. This notice is for information and planning purposes only and is neither to be construed as a commitment by the Government nor will the Government pay for information solicited. Respondents are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked 'Proprietary' will be handled accordingly. Responses to the RFI will not be returned. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. If a solicitation is released it will be synopsized in FedBizOpps (FBO) at https://www.fbo.gov. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis. Background: In support of the U.S. Army Medical Materiel Development Activity's (USAMMDA) mission to develop and manage medical materiel to protect and sustain the Warfighter, this request for information is seeking entities interested in Good Manufacturing Practice (GMP) Storage and Good Laboratory Practice (GLP) Archiving of Clinical and Non-Clinical Research Materials, Kitting, and Testing of Department of Defense (DoD) Items supporting medical product development efforts. Purpose and Objectives: This request for information is seeking entities interested in performing the overall description to include: 1) current Good Manufacturing Practice (cGMP) storage and Good Laboratory Practice (GLP) archiving of items in an appropriate manner that preserves the integrity and quality of the items and prevents degradation; 2) kitting of investigational products to support clinical investigations; and 3) testing of investigational medical products (e.g., vaccines or pharmaceuticals), as discussed in the Specific Tasks below, required to support applications to the U.S. Food and Drug Administration (FDA). Items to be stored include: formalin-preserved wet tissue specimens, paraffin-embedded blocks, prepared slides of tissues, paper records, electronic records, data, video tape, equipment, and frozen, controlled room temperature or refrigerated items such as drugs, biologics and medical devices. A subset of these items are required to be stored and archived in accordance with cGMP and GLP as specified in 21 CFR 211.142 (b) and 21 CFR 58, respectively. The Contractor should be following the GLP archiving quote mark best practices quote mark, even if quote mark best practices quote mark requirements entail more than the minimum requirements of the GLP regulations as specified in 21 CFR 58. The Contractor must maintain items to be stored in accordance with the GLP regulations such that the facility is always ready to undergo a formal audit by the FDA for compliance with the GLP regulations, with no FDA Form 483 being issued. Dates: Interested entities shall forward submissions via email to toloria.s.duvall.civ@mail.mil no later than 5:00 pm (EST) 27 August 2015. Telephonic communication will not be considered as submission or receive a response. Questions: All questions pertaining to the RFI are due by 12:00 pm (EST) 12 August 2015. Only one set of questions per vendor will be accepted. Telephone requests will not be entertained. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. Instructions to Respondents: The subject header of the email for submission of questions and/or the RFI responses shall be: USAMMDA DRAC GMP Storage and GLP Archiving White papers should adhere to the following formatting and outline instructions: Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their capability to store and archive clinical and non-clinical products for the Government-sponsored product development efforts. Companies responding to this notice must provide complete contact information (telephone, address, email address). Respondents must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts. Format specifications include 12-point font, single spaced, single sided, 8.5 by 11-inch paper with 1-inch margins. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF. Disclaimer and Important Notes: The purpose of this RFI notice is to gain market knowledge. 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 solution and 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: All 'Proprietary', 'Classified', 'Confidential', or 'Sensitive' information shall be marked as such, and will be treated accordingly. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH15RFI/listing.html)
- Record
- SN03814023-W 20150730/150729000437-a19c2f29b46e8ec5ed805e65590485c7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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