SPECIAL NOTICE
A -- Request for Information (RFI)--USAMMDA OQM External Audit
- Notice Date
- 9/23/2015
- Notice Type
- Special Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting 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
- W81XWH15RFI23
- Archive Date
- 9/22/2016
- 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: Office of Quality Management (OQM) 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. 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 medical products to protect and sustain the Warfighter, this request for information is seeking entities interested in performing: a gap analysis and assessment of USAMMDA's compliance with U.S. Food and Drug Administration (FDA) pharmaceuticals requirements; a mock FDA audit; and consultation on process improvement based on assessment findings. Purpose and Objectives: This request for information is seeking entities interested in performing a gap analysis of USAMMDA's processes, with respect to compliance with FDA regulatory obligations for medical products in the post Phase 3 stage of development. The gap analysis and assessment would be followed by a mock FDA audit on a selected drug candidate slated for New Drug Application (NDA) submission and associated FDA pre-approval inspection, and an option for consultation on identified current Good Manufacturing Practice (cGMP), current Good Laboratory Practice (cGLP), and current Good Clinical Practice (cGCP) non-conformances with suggested corrective actions and process improvements. USAMMDA manages several medical product development efforts for which the U.S. Army Office of The Surgeon General serves as the Sponsor, and as such, must meet a variety of FDA regulatory obligations. However, this effort will be limited to in-house regulatory management activities, as clinical studies and manufacturing are all performed by other organizations with oversight from USAMMDA. Activities include regulatory strategy development, electronic Common Technical Document (eCTD) publishing, clinical trial monitoring, safety reporting and surveillance, data management, biostatistics, regulatory document management, medical writing, trial master file (TMF) maintenance, product accountability, product quality oversight, oversight of manufacturing, and the quality and training programs. It is anticipated that this task will require approximately 3 months of planning and preparations and one to two weeks on-site for the audit. Dates: Interested entities shall forward submissions via email to toloria.s.duvall.civ@mail.mil no later than 5:00 pm (ET) 22 October 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 (ET) 06 October 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 OQM External Audit 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 perform the tasks described above, and a rough order of magnitude (ROM) estimate of the cost to perform the services. 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 and favorable experience working with the FDA. Format specifications include 10-point to 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/W81XWH15RFI23/listing.html)
- Record
- SN03901201-W 20150925/150924000811-5cd7b11d7dac0f9fcc7969cec00dc438 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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