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FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 11, 2015 FBO #5131
SOURCES SOUGHT

70 -- Sources Sought Notice/Request for Information: StartingPoint common technical document (CTD)

Notice Date
12/9/2015
 
Notice Type
Sources Sought
 
NAICS
511210 — Software Publishers
 
Contracting Office
Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
 
ZIP Code
21702-5014
 
Solicitation Number
W81XWH-16-T-0037
 
Archive Date
1/7/2016
 
Point of Contact
Abraham G. Pottenger, Phone: 3016192294
 
E-Mail Address
abraham.g.pottenger.civ@mail.mil
(abraham.g.pottenger.civ@mail.mil)
 
Small Business Set-Aside
N/A
 
Description
1.0 SUBJECT: In support of the U.S. Army Medical Materiel Development Activity's mission to develop and manage medical materiel to protect and sustain the Warfighter, this request for information (RFI) is seeking entities interested in providing Brand Name only maintenance, support, and licensing for an existing Accenture StartingPoint common technical document (CTD) authoring template suite containing more than 275 individual CTD authoring templates that support U.S. regulatory submissions. 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this RFI are not offers and will not be accepted by the Government to form a binding contract. Responders 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. At this time, questions concerning the composition and requirements for a future request for proposal will not be addressed. 3.0 DESCRIPTION: This RFI is seeking entities interested in providing Brand Name only annual maintenance, support, and licensing of a suite of Microsoft Word Accenture StartingPoint CTD content authoring templates that each relate to a specific component of the CTD framework. Specifically, the Government is seeking a company to maintain, support, and license the existing template suite by providing timely content updates to Accenture StartingPoint CTD templates that support U.S Food and Drug Administration (FDA) regulatory submissions. Interested entities should have demonstrated experience with the instructional component of Accenture StartingPoint CTD templates, which includes the ability to effectively interpret International Conference on Harmonisation (ICH) guidance documents, as well as licensing for use and support of the product. The Accenture StartingPoint CTD content templates are used in the development of regulatory submission documents for inclusion in clinical product applications sponsored by The Surgeon General, Department of the Army. Accenture StartingPoint CTD content template capabilities requiring maintenance, support, and licensing include, but are not limited to: •Predefined heading styles, fonts, margins, and table formats •Auto-numbered heading styles •Hidden instructional text from the International Conference on Harmonisation (ICH) CTD guidances •Separate template file that provides at least 108 quick-access, macro-based buttons for template styles and functionality •Document information fields based on a separate initialization file that sets parameters for values repeated across documents •Automated table generation, and insertion and management of footnotes and headings across multiple pages •Document validation functionality to fix invalid styles, fonts, and formatting errors, including generation of an error report •Document reformatting support that allows authors to map and convert improperly styled documents to the specified style •Documentation support for user manuals and frequently asked questions •Physician labeling rule functionality for formatting full prescribing information into a one- or two-column format •Formally validated in the operating environment of Microsoft Windows 7/Microsoft Office 2010 (32 bit) •Template modules include; ANDA, Module 1 US, Module 1 EU, Module 1 CA, Module 2 Summaries, Module 3 Quality, Module 4 Safety, Module 5 Efficacy, Paper & Hybrid. 4.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish in writing, a 2- to 3-page (not including cover page, index, or list of references) synopsis of their capability to provide maintenance, support, and licensing for Accenture StartingPoint CTD content authoring template suite. Entities responding to this notice must provide complete contact information (telephone, address, e-mail address). Responders must identify their company's business size (based on the NAICS size standard) and business status (i.e., small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Responders should also include information regarding any prior experience with U.S. Government contracts and favorable experience working with the FDA. 5.0 SUBMISSION CONTACT INFORMATION: Interested entities should forward submissions to Abraham Pottenger at abraham.g.pottenger.civ@mail.mil no later than the 2:00 pm ET on 23 December 2015. Communication via telephone will not be considered as submission or receive a response.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-16-T-0037/listing.html)
 
Place of Performance
Address: U.S. Army Medical Materiel Development Activity, 1430 Veterans Way, Fort Detrick, Maryland, 21702, United States
Zip Code: 21702
 
Record
SN03965560-W 20151211/151209234910-a577bc08541a4a5a37d716d49061b691 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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