Limiting-Competition-under-SAT_ACC_21Q0054_Redacted.pdf

Control No: JA-21-04-00282

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: The U.S. Army Medical Research Acquisition Activity (USAMRAA), located at

820 Chandler Street, Fort Detrick, MD 21702.

2. Description of Action: The U.S. Army Medical Research and Development Command (USAMRDC), Office of Regulated Activities (ORA, Fort Detrick, MD), has a requirement for Common Technical Document (CTD) authoring template suite software licenses, technical support and maintenance.

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number _ _

Blanket Purchase Agreement (BPA) Number _

Order/BPA# against FSS Contract #_ _ _ _

Order # against Multiple Award IDIQ Contract Name or

Order # against a single award IDC Contract

Modification # to existing PO/TO/DO/Call Order

Pricing/Contract Type: Fixed Price Time & Materials/Labor Hours Cost Reimbursable

Hybrid

Funds: Operations & Maintenance, Army (OMA)

FY:

Name of Proposed Contractor(s) and Address:

Accenture Federal Services LLC Street Address:

City, State, Zip:

Phone:

DUNS:

Cage Code:

Brand Name Buy: Yes No

3. Description of Services or Supplies: The required services entail an annual maintenance agreement, which includes technical support and product updates for the existing Accenture Federal Services LLC StartingPoint® CTD templates that are currently deployed within ORA. ORA (formerly the Division of Regulated Activities and Compliance (DRAC)), purchased proprietary, macro- based, Microsoft Word electronic Common Technical Document (CTD) “StartingPoint” templates from Octagon Research Solutions, Inc. (now Accenture Federal Services LLC), in February 2009. Accenture Federal Services LLC “StartingPoint” CTD Templates enable rapid deployment of regulatory authoring standards across functional areas to facilitate efficient authoring of all components of the CTD along with submissions to the U.S. Food and Drug Administration. This requirement will allow for continuation of product updates, and support for use of the existing templates. Templates include instructional text from the International Council for Harmonization (ICH) guidance documents as well as automation of frequently used authoring functions. The content templates and the associated administration files that govern their automation require frequent updates. Updates consist of new or updated content templates, and issue resolutions. In addition, new functions may require additional technical support regarding how the templates work and how to use the templates, beyond that which can be read in a user guide.

Minimum Essential Characteristics (MECs):

Shall include maintenance for existing Accenture StartingPoint Common Technical Document (CTD) authoring template suite containing more than 450 CTD Templates and over 100 Medical Device templates.

Shall include support for existing Accenture StartingPoint Common Technical Document (CTD) authoring template suite.

Shall include licensing for existing Accenture StartingPoint Common Technical Document (CTD) authoring template suite.

This approval is being requested for a new firm fixed price contract with a 60 month overall period of performance (consisting of a 12 month base period and four 12 month option periods).

Maintenance, Licensing and Support:

Base Period: 04 May 2021 to 03 May 2022 Value: $

Option Period 1: 04 May 2022 to 03 May 2023 Value: $ Option Period 2: 04 May 2023 to 03 May 2024 Value: $ Option Period 3: 04 May 2024 to 03 May 2025 Value: $ Option Period 4: 04 May 2025 to 03 May 2026 Value: $

Optional item (Medical Device Templates) Base Period: 04 May 2021 to 03 May 2022 Value: $_ Option Period 1: 04 May 2022 to 03 May 2023 Value: $_ Option Period 2: 04 May 2023 to 03 May 2024 Value: $_ Option Period 3: 04 May 2024 to 03 May 2025 Value: $_ Option Period 4: 04 May 2025 to 03 May 2026 Value: $_

4. Authority:

Total: $

Total: $

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited:

The proposed contractor for this action is Accenture Federal Services LLC. Accenture Federal Services LLC is uniquely qualified to perform these services. Accenture Federal Services LLC is the sole developer and provider of any licenses, product updates or technical support to these templates, and there is no maintenance support reseller available.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, apply and will be followed, or do not apply due to an exception at _ is for an amount not expected to exceed the simplified acquisition amount.

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

Action is NOT a brand name restriction and is under $150K, no posting required

Action is a brand name restriction, under $25K, no posting required

Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

FAR 6.305(f)

FAR 8.405-6(b)(3)(iii)(A)

FAR 8.405-6(b)(3)(iii)(B)

FAR 8.405-6(b)(3)(iii)(C)

FAR 16.505(a)(4)(iii(C)

7. Market Research: RFI PANMRA-20-P-0000 003271_PANMRA-21-P-0000-002181 was posted to BETSAM.gov on 17 March 2021 (seeking sources who could provide the required Accenture Federal Services LLC StartingPoint® authoring template suite software licenses, technical support and maintenance) and garnered no vendor response.

During market research, ORA contacted five (5) vendors for information about their CTD authoring templates products to locate products that can meet the Governments requirement or could provide the required Accenture Federal Services LLC StartingPoint® authoring template suite software licenses, technical support and maintenance and at replacing the software template.

Synchrogenix and Freyr Solutions offer a macro-based, CTD template suite, but each lacks the breadth and depth of content required by ORA. Aquila Solutions and Sage Solutions offer non-macro-based CTD template suites that lack the capability to meet ORA’s requirements for automation of frequently used authoring functions. DXC Technology did not respond to email inquiry. In addition, market research was conducted through web searches and product demonstrations. A description of CTD authoring templates products located and associated costs are outlined in the table below.

Five (5) year costs for alternative CTD authoring template packages:

Vendor Location POC Capability Cost per 60

Months (see breakout below)

Synchrogenix Wilmington, DE

Name:

Phone:

Email:

Provides 240+ macro-based CTD authoring templates that can automate frequently used authoring functions.

Freyr Solutions Princeton, NJ

Name:

Provides 75+ macro-based CTD authoring templates that can automate frequently used authoring functions.

Aquila Solutions Warner Robins, GA

Name:

Provides non-macro-based authoring templates which lack the capability to automate frequently used authoring functions.

Sage Solutions San Diego, CA

Name:

Provides non-macro-based authoring templates which lack the capability to automate frequently used authoring functions.

In summary, no CTD software is available in the market provides the functions that ORA requires and no sources were located that could provide the required Accenture Federal Services LLC StartingPoint® authoring template suite software licenses, technical support and maintenance (except Accenture Federal Services LLC).

8. Other Facts: A Notice of Intent will be posted in accordance with FAR Part 5.202 to inform the market place that a the Government intends to procure the required products on a sole source basis. Note that all three previous contracts were with the same source.

Previously Competed:

Contract: W81XWH-09-P-0042 in the amount of Contractor: Octagon Research Solutions, Inc.

Award Date: 22 October 2008 Competitive Status: (Full and Open, only one offer)

Contract: W81XWH-11-P-0268 in the amount of Contractor: Octagon Research Solutions, Inc.

Award Date: 21 April 2011 Competitive Status: Sole Source (FAR Part 6.302-1 (Only One source available))

W81XWH-16-P-0140, in the amount of Contractor: Accenture Federal Services, LLC Award Date: May 2016 Competitive Status: (FAR Part 6.302-1 (Only One source available))

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Title: Office of Regulated Activities, Regulatory Systems Manager Date: See Electronic Signature.

Signature:

10. Contracting Officer Certification/Approval: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name:

Title: USAMRAA Contracting Officer Date: See Electronic Signature.

Signature: