COMBINED SYNOPSIS W81XWH21Q0054.pdf

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Issue Date: 15 April 2021

2. Close Date: 23 April 2021; 1000 AM Eastern Standard Time (EST)

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler

Street, Fort Detrick, MD 21702

4. Requiring Activity: The U.S. Army Medical Research and Development Command (USAMRDC), Office of

Regulated Activities (ORA)

5. Subject: Common Technical Document (CTD) Authoring Template Suite Software Licenses, Technical Support and Maintenance

6. Solicitation Number: W81XWH-21-Q-0054

7. Description of Requirement: The U.S. Army Medical Research and Development Command (USAMRDC), Office of Regulated Activities (ORA) requires Common Technical Document (CTD) authoring template suite software licenses, technical support and maintenance.

7.1. This is a combined synopsis/solicitation issued as a Request for Quote (RFQ) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are requested.

7.2. This solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular (FAC) 2021-02; effective 23 October 2020.

7.3. The North American Industry Classification System (NAICS) code is 518210 Data Processing, Hosting, and

Related Services with a Small Business Size Standard of $35,000,000.00.

7.4. Contract award shall be made on a best value basis using Lowest Price Technically Acceptable “LPTA” approach.

7.5. The Contract Line Item Numbers (CLINs) numbers and items, quantities units of measure, and description are identified under the Supplies/Services Section of the RFQ.

7.6. The anticipated Period-of- Performance (POP): see Statement of Need (SoN) and DELIVERY INFORMATION for POP.

8. Point-of-Contact: The point-of-contact for this acquisition is Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil. No telephone calls will be accepted.

9. Instructions for the Preparation and Submission of Quotes.

9.1. Quotes shall be prepared in accordance with this solicitation and FAR provision 52.212 -1 Instructions to

Offerors- Commercial Items including the Addendum to 52.212-1, which is included with the attached RFQ.

9.2. All quotes shall be evaluated in accordance with the evaluation criteria identified in FAR 52.212-2 Evaluation—

Commercial Items included with the attached RFQ.

9.3. The FAR clause 52.212-4 Contract Terms and Conditions-Commercial Items applies to this acquisition.

Additional contract requirements and terms and conditions are identified in the attached RFQ.

9.4. The FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders

– Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and marked which are applicable to this acquisition.

9.5. The Government reserves the right to reject any or all quotes, and to award no contract at all, depending on the quality of the quote (s) submitted and the availability of funds.

9.6. Questions: Questions shall be submitted via e-mail to Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil, no later than (NLT) 19 April 2021 at 1000 AM EST. Questions received after this date will not be accepted. An Amendment to this RFQ will be posted to Beta.SAM.gov with responses to the questions received. Only one set of questions per Contractor will be accepted. No telephone calls will be accepted.

9.7. Quotes: Quotes in response to this RFQ are due via e-mail NLT 23 April 2021 at 1000 AM EST to Ms. Maribel

C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil.

9.8. The Offeror shall agree to honor proposed prices for 60 calendar days from the due date for receipt of quotes.

Section SF 1449 - CONTINUATION SHEET

STATEMENT OF NEED

STATEMENT OF NEED

COMMON TECHNICAL DOCUMENT TEMPLATES

FOR THE

U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (USAMRDC) OFFICE OF

REGULATED ACTIVITIES (ORA)

1. INTRODUCTION

The Office of Regulated Activities (ORA) within USAMRDC is a multidisciplinary team of regulatory affairs and clinical compliance professionals dedicated to supporting the USAMRDC mission of developing U.S. Food and

Drug Administration (FDA) regulated medical products for the warfighter.

2. PURPOSE

The ORA requires Common Technical Document (CTD) authoring templates, training and maintenance. The CTD templates are used to facilitate standardized authoring and reviewing intended for regulatory submissions to the

FDA. Without the CTD templates, the USAMRDC Direct Reporting Units (DRU) and ORA medical writing personnel are forced to rely on manual review and conversion of submission documents to conform to FDA and

International Conference of Harmonisation (ICH) standards for regulatory submission documents.

3. SCOPE OF WORK

3.1. Task 1 – Supply Support.

1. The Contractor shall provide a complete set of granular CTD and Medical Device templates for all sections in Module 1 through Module 5 including appendices, a style guide, and any associated administration files to support U.S. FDA regulatory submissions for all application types during the period of performance of the established contract, such as;

• Investigational New Drug (IND)

• New Drug Application (NDA)

• Abbreviated New Drug Application (ANDA)

• Biologics License Application (BLA)

• Investigational Device Exemption (IDE)

• Premarket Notification (510(k))

• Premarket Approval (PMA)

2. The CTD templates shall include functionalities to increase writing efficiency and maintain formatting consistency, such as grouping series of commands or steps for frequently performed tasks into single button clicks.

Macro functionality examples include, but are not limited to:

• Single click symbol tools

• Reference manager

• Multiple word search function

• Cross-linking and link insertion (i.e., to page numbers, tables, figures, and references)

• Title case

• Tables and figures addition and formatting

• Creating a Table of Contents (TOC), List of Tables (LOT), List of Figures (LOF)

• Updating fields

• Easy to read and aesthetically pleasing formatting styles including numbered and non-numbered bolded headings and sub-headings, indented Table of Contents, appendices, normal text, footnotes, and captions

3. The CTD templates shall group series of commands or steps for frequently performed tasks into single and minimal button clicks to reduce the amount of work for repetitive functions, increase productivity, and include tools for tables, figures, linking, List of Tables, List of Figures, Table of Contents, styles, footnotes, and title case with the ability to automatically update fields. Macro functionality examples include, but are not limited to:

• Single click symbol tools

• Reference manager

• Multiple word search function

• Insert links (i.e., to page number)

• Easy to read and aesthetically pleasing formatting styles (e.g. indented Table of Contents, numbered and bolded headings)

4. The templates shall allow application of template-specific functionality to existing documents not authored on Contractor’s CTD templates, or a simplified method, i.e., minimal mouse clicks, to transfer content to CTD templates with application of standardized formatting.

5. The Contractor shall ensure that CTD templates incorporate instructional text, formatting standards and regulatory and health authority guidance as recommended by the FDA, ICH, TransCelerate BioPharma and adopted by the U.S. FDA.

6. The Contractor shall provide access to user guides and technical documents.

3.2. Task 2 – Technical Accessibility.

1. Media Availability (Access): Vendor shall provide access to all technical data.

2. Technical Data Accessibility: DoD Staff shall have access to application software, any diagnostic software, operator, and service technical data required to operate and maintain the system on the DoD network.

3. The templates and all associated files and documentation shall be compatible with EDMS (Open Text

Content Server electronic document management system).

4. The Contractor shall ensure compatibility with current Army desktop operating systems and office productivity software, (as of August 2020 is Microsoft Windows 10, Microsoft Word 2013 (32 bit), Microsoft Word

2016 (32 bit), and Microsoft Office 365).

5. The Contractor shall ensure the template files are compatible with Adobe Acrobat pdfmaker/conversion and can be published in electronic Common Technical Document (eCTD) publishing software.

6. The templates shall be usable by personnel without direct access to ORA’s internal network drives.

3.3. Task 3 – Training and Training Support

1. The Contractor shall provide a Training Plan for Department of Defense (DoD) Medical Writing Staff and

Systems Managers for the proposed system as configured to include the following topics: preparation for use and installation, software applications training, use instructions, troubleshooting, software updates and security patch instructions (if applicable).

2. The Contractor shall provide all available user and maintainer manuals, training videos, and documentation.

3. The Contractor shall offer, as part of the contract, training options for both individual and group service personnel that can be ordered as needed.

4. The online (and on DVD) training should include all the preventive and corrective maintenance services necessary to operate, maintain, and sustain the system its useful life.

3.4. Task 4 – Compliance Planning and Management

1. The CTD Templates must be and remain compliant with the most current U.S. FDA and ICH recommendations policies and regulations.

2. The Contractor shall provide a warranty for a period of 12 months from time of delivery. Warranty shall include all parts, software updates (if applicable), labor technical support, and shipping during the warranty period.

3. The Contractor shall notify the Army, of all notices affecting the system for the useful life of the system.

5. PERIOD OF PERFORMANCE/DELIVERY DATE:

The anticipated period of performance of this contract is five (5) years (base plus four (4) option years). The base year includes the purchase of the CTD Templates and any associated administrative files and the scope of the work identified in this Statement of Need (SoN). The four (4) option years shall include periodic updates of the entire

CTD Templates suite.

Base Year: 04 May 2021 – 03 May 2022

Option Year 1: 04 May 2022 – 03 May 2023

Option Year 2: 04 May 2023 – 03 May 2024

Option Year 3: 04 May 2024 – 03 May 2025

Option Year 4: 04 May 2025 – 03 May 2026

6. FEDERAL HOLIDAYS

The following Federal holidays are observed and no work or deliveries shall occur on the dates specified. Any of the below holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday.

a. New Year’s Day, 1 January

b. Martin Luther King’s Birthday, 3rd Monday in January

c. President’s Day, 3rd Monday in February

d. Memorial Day, last Monday in May

e. Independence Day, 4 July

f. Labor Day, 1st Monday in September

g. Columbus Day, 2nd Monday in October

h. Veteran’s Day, 11 November

i. Thanksgiving Day, 4th Thursday in November

j. Christmas Day, 25 December

7. REFERENCES

FDA Guidance for Industry – “Providing Regulatory Submissions in Electronic Format — Certain Human

Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” Revision 7.

February 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications-0.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Each

Maintenance, Licensing, Support

FFP

The Contractor shall provide maintenance, licensing and support for Accenture

StartingPoint CTD Templates Software.

Base period of performance (POP) 04 MAY 2021 through 03 MAY 2022.

FOB: Destination

PSC CD: DA10

NET AMT

0002 1 Each

Medical Device Templates

FFP

StartingPoint CTD Medical Device Templates Software.

Base period of performance (POP) 04 MAY 2021 through 03 MAY 2022.

1001 1 Each

OPTION Maintenance, Licensing, Support

FFP

Period of performance (POP) 04 MAY 2022 through 03 MAY 2023.

1002 1 Each

OPTION Medical Device Templates

FFP

Period of performance (POP) 04 MAY 2022 through 03 MAY 2023.

2001 1 Each

OPTION Maintenance, Licensing, Support

FFP

Period of performance (POP) 04 MAY 2023 through 03 MAY 2024.

2002 1 Each

OPTION Medical Device Templates

FFP

Period of performance (POP) 04 MAY 2023 through 03 MAY 2024.

3001 1 Each

OPTION Maintenance, Licensing, Support

FFP

Period of performance (POP) 04 MAY 2024 through 03 MAY 2025.

3002 1 Each

OPTION Medical Device Templates

FFP

Period of performance (POP) 04 MAY 2024 through 03 MAY 2025.

4001 1 Each

OPTION Maintenance, Licensing, Support

FFP

Period of performance (POP) 04 MAY 2025 through 03 MAY 2026.

4002 1 Each

OPTION Medical Device Templates

FFP

Period of performance (POP) 04 MAY 2025 through 03 MAY 2026.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

1001 Destination Government Destination Government

1002 Destination Government Destination Government

2001 Destination Government Destination Government

2002 Destination Government Destination Government

3001 Destination Government Destination Government

3002 Destination Government Destination Government

4001 Destination Government Destination Government

4002 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 04-MAY-2021 TO

03-MAY-2022

N/A USA MED RESEARCH MAT CMD

JAMI CLEVENGER

1430 VETERANS DRIVE

FORT DETRICK MD 21702-5009

301-619-4659

W23RYX

0002 POP 04-MAY-2021 TO

03-MAY-2022

N/A (SAME AS PREVIOUS LOCATION)

1001 POP 04-MAY-2022 TO

03-MAY-2023

N/A (SAME AS PREVIOUS LOCATION)

1002 POP 04-MAY-2022 TO

03-MAY-2023

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 04-MAY-2023 TO

03-MAY-2024

N/A (SAME AS PREVIOUS LOCATION)

2002 POP 04-MAY-2023 TO

03-MAY-2024

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 04-MAY-2024 TO

03-MAY-2025

N/A (SAME AS PREVIOUS LOCATION)

3002 POP 04-MAY-2024 TO

03-MAY-2025

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 04-MAY-2025 TO

03-MAY-2026

N/A (SAME AS PREVIOUS LOCATION)

4002 POP 04-MAY-2025 TO

03-MAY-2026

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.204-7 System for Award Management OCT 2018

52.204-13 System for Award Management Maintenance OCT 2018

52.204-16 Commercial and Government Entity Code Reporting AUG 2020

52.204-18 Commercial and Government Entity Code Maintenance AUG 2020

52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.204-21 Basic Safeguarding of Covered Contractor Information

Systems

JUN 2016

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.242-15 Stop-Work Order AUG 1989

52.247-34 F.O.B. Destination NOV 1991

252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7003 Control Of Government Personnel Work Product APR 1992

252.204-7006 Billing Instructions OCT 2005

252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

DEC 2019

252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

MAY 2016

252.204-7016 Covered Defense Telecommunications Equipment or Services

-- Representation

DEC 2019

252.204-7017 Prohibition on the Acquisition of Covered Defense

Telecommunications Equipment or Services -- Representation

DEC 2019

252.204-7018 Prohibition on the Acquisition of Covered Defense

Telecommunications Equipment or Services

JAN 2021

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013

252.225-7001 Buy American And Balance Of Payments Program-- Basic DEC 2017

252.225-7002 Qualifying Country Sources As Subcontractors DEC 2017

252.225-7048 Export-Controlled Items JUN 2013

252.225-7974 (Dev) Representation Regarding Business Operations with the

Maduro Regime (DEVIATION 2020-O0005)

FEB 2020

252.232-7010 Levies on Contract Payments DEC 2006

252.239-7009 Representation of Use of Cloud Computing SEP 2015

252.239-7010 Cloud Computing Services OCT 2016

252.239-7017 (Dev) Notice of Supply Chain Risk (DEVIATION 2018-O0020). FEB 2019

252.239-7018 (Dev) Supply Chain Risk (DEVIATION 2018-O0020). FEB 2019

252.244-7000 Subcontracts for Commercial Items JAN 2021

252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services--

Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-

Commercial Items. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the

Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause

52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or

Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM)

(https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [] will, [] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds

"will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [] does, [] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as

OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered

(include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as

OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered

(include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES--REPRESENTATION (OCT

2020)

(a) Definitions. As used in this provision, “covered telecommunications equipment or services” and "reasonable inquiry" have the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain

Telecommunications and Video Surveillance Services or Equipment.

(b) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM)

(https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services”.

(c) Representations.

(1) The Offeror represents that it [ ___ ] does, [ ___ ] does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument.

(2) After conducting a reasonable inquiry for purposes of this representation, the offeror represents that it [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services.

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JUN 2020)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in paragraph 7.3., “North American Industry

Classification System (NAICS)” 518210 – Data Processing, Hosting, and Related Services of the Combined

Synopsis/Solicitation Instructions. However, the small business size standard for a concern which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

https://www.sam.gov/

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with subpart 4.10 of the

Federal Acquisition Regulation), or alternative commercial items for satisfying the requirements of this solicitation.

Each offer submitted will be evaluated separately.

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the

Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent

Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers.

Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation. (1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA

Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC

20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision.

Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point

(DoDSSP) by--

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or https://assist.dla.mil/online/start/ http://quicksearch.dla.mil/ http://assistdocs.com/ https://assist.dla.mil/wizard/index.cfm

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone

(215) 697-2667/2179, Facsimile (215) 697-1462.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier. (Applies to all offers that exceed the micro-purchase threshold, and offers at or below the micro-purchase threshold if the solicitation requires the Contractor to be registered in the System for Award

Management (SAM).) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the Offeror's name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the

Offeror to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) Reserved.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

ADDENDUM TO 52.212-1 INSTRUCTI

ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS

A.1. Instruction to Offerors - The Offerors response to this solicitation shall be legible and comprehensive to enable the Government to conduct the technical evaluation. The information shall be precise, factual, and complete.

Failure to submit all information concurrently and in accordance with these instructions shall render the Offeror’s quote “Unacceptable”. Quotes shall provide a minimum offer acceptance period of 60 days (including an agreement to hold the prices in offer firm) after the required date for receipt of quotes.

The quote shall be submitted in two separate volumes:

Volume I – Non-Price Factors (Technical Approach/Past Performance) http://www.sam.gov/

Volume II - Price

Volume I - Non-Price Factors. Volume I shall not include any pricing information.

Volume I- shall contain the following on the cover page

Complete company name and address

Company POC including title, email address and phone number

Cage Code

DUNS Number

In accordance with file submission requirements given in this section, the offeror shall submit the following:

A.1.1. Evaluation Factor I - Technical Approach - The offeror shall provide sufficient technical documentation documenting the following:

The offeror shall demonstrate an understanding of and capability to meet all of the requirements of the Statement of

Need (SoN), Minimum Essential Characteristics (MECs) and as described throughout this RFQ. The MECs are identified in this RFQ.

The offeror shall provide a statement that they are registered in SAM (System for Award Management). The statement must also state that the SAM registration is current and that the offeror is listed under the NAICS code utilized for this RFQ - 518210 Data Processing, Hosting, and Related Services.

The offeror shall complete the following provisions and return them as part of their quote:

-52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (NOV 2020)

ALTERNATE I (OCT 2014)

- 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

- 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES--REPRESENTATION (OCT

2020)

A.1.2. Evaluation Factor II - Past Performance – The offeror shall describe its past performance on one (1) contract it has held within the last three years that are for the same or similar services to that which is detailed in this solicitation, or affirmatively state the offeror possesses no relevant past performance directly related to or similar past performance.

The offeror shall provide the following information in their quote-

1. POC information – Name, Title, Phone Number, E-Mail Address, Agency Name and Address.

2. Contract Number and Task Order number(s), if applicable.

3. Name of contractor to whom the contract was awarded. Name of contractor who performed maintenance and warranty services, if different from awardee. Provide the CAGE Code and DUNS numbers of both the awardee and the contractor who performed the service(s). If the contractor to whom the contract was awarded and the contractor who performed the services are different, it must be clear which company is which. The correlation of the awardee to the offeror (prime or subcontractor) must be clear.

4. Dates when services were provided.

5. Place(s) of performance.

6. Describe the offeror’s role – prime, subcontractor, partner, mentor, protégé, etc.

7. The offeror shall provide information on problems encountered on the identified contract(s) and the offeror’s correcting actions (if applicable).

The Government will evaluate the past performance to determine if the reference is recent and relevant.

Past performance will be verified through CPARS reports or through contacting the POC (at the Government’s discretion).

Page limit for Volume I – Non-Cost Factors – Not to exceed 15 pages (excluding a Cover Sheet and Table of

Contents)

A.1.3 Volume II – Price - The Offeror shall provide a unit price and total price for each Contract Line Item Number

(CLIN) identified within this solicitation. Offerors shall use Section B of this solicitation to provide the unit price and total price for CLINs 0001 through 4002 as well as provide the total proposed price. The Government anticipates award of a Firm-Fixed Price (FFP) contract and the Offeror shall propose FFP pricing on all CLIN items.

All CLINs shall be priced.

Volume II has no page limit.

A.2. Instructions to Offerors: The Offerors response to this RFQ shall be legible and comprehensive to enable the

Government to conduct the technical evaluation. The information shall be precise, factual, and complete. Failure to submit all information concurrently and in accordance with these instructions shall render the Offeror’s quote

“unacceptable”.

A.3. The Offeror’s quote shall include the product literature which clearly documents the offered of Common

Technical Document (CTD) authoring templates, ongoing maintenance and support, and appropriate training products identified in the Statement of Need (SoN), Minimum Essential Characteristics (MECs) and as described throughout this RFQ.

A.4. The Common Technical Document (CTD) authoring templates, ongoing maintenance and support, and appropriate training offered must be new. Offerors offering used or remanufactured equipment/products shall be rated “Unacceptable”.

A.5. Shipping shall be Free-On Board (FOB) Destination IAW FAR 52.247-34. The shipping location is:

U.S. Army Medical Research and Development Command (USAMRDC)

Office of Regulated Activities (ORA)

1430 Veterans Drive

Fort Detrick, MD 21702-5009

A.6. The product offered must be new. Offerors offering used or remanufactured products are “Unacceptable”.

A.7. Offerors are encouraged to offer the Government discounts where appropriate.

A.8. Questions: All questions pertaining to the RFQ shall be submitted via e-mail to Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil no later than 19 April 2021 at 1000 AM EST. The subject header of the e-mail submission of questions shall be: Common Technical Document (CTD) authoring templates, ongoing maintenance and support, and appropriate training and RFQ # W81XWH-21-Q-0054. Questions received after this date will not be accepted.

A.9. RFQ Due Date: Response to this RFQ is due via e-mail no later than 23 April 2021 at 1000 AM EST via e-mail to Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil. No telephone calls will be accepted.

A.10. Period-of-performance (POP): See Statement of Need (SoN) and DELIVERY INFORMATION for POP.

mailto:maribel.c.fratina.civ@mail.mil mailto:maribel.c.fratina.civ@mail.mil

CLAUSES INCORPORATED BY FULL TEXT

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be provide the best value to the Government. Best value is defined as the lowest price, technically acceptable quote

The following factors shall be used to evaluate offers:

Evaluation Factor I - Technical Approach

Evaluation Factor II - Past Performance

Evaluation Factor III - Price

Offerors shall receive a rating of acceptable for Evaluation Factor I and Evaluation Factor II and Evaluation Factor

III shall be determined to be complete / fair and reasonable, in order for an offeror to be eligible for award.

(b) The Government intends to award based on initial offers (without discussions). The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary. The Government intends to award a single contract as a result of this RFQ.

Evaluation Factor I - Technical Approach

The Offerors quote will be evaluated for completeness to determine that the offeror has completed and provided the required provisions and completed and provided the required OCI attachment.

Offeror will be evaluated on its ability to demonstrate understanding of and capability to meet all of the requirements of the MECs. The offeror’s approach will be evaluated on its feasibility, its comprehensiveness, and the degree to which the offeror demonstrates how the requirements identified in the MECs will be successfully accomplished.

Evaluation Factor I will be rated on an Acceptable / Unacceptable (Pass / Fail) basis.

Evaluation Factor II - Past Performance

The Past Performance evaluation will result in an assessment of the offeror’s probability of meeting the solicitation requirements.

The Government reserves the right to utilize other information not provided by the vendor and will evaluate information readily available. It is the responsibility of the offeror to ensure names and phone numbers of points of contact are verified and accurate.

The Government will evaluate past performance for -

Recency- Contract cited have not ended more than three years prior to the closing date of the solicitation.

Relevancy- Present/past performance effort involved a similar scope and magnitude of effort and complexities this solicitation requires.

If a reference contract is determined to be “not recent and relevant” (after review of the offeror’s quote), then the reference contract will not be evaluated further.

Evaluation Factor II will be rated on an Acceptable / Unacceptable (Pass / Fail) basis, unless the offeror possess no relevant past performance.

In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror will not be evaluated favorably or unfavorably on past performance (FAR

15.305(a)(2)(iv)). The offeror will receive a neutral rating.

Evaluation Factor III – Price.

Price will be evaluated on completeness and reasonableness. Price is not rated or scored.

Completeness – The offeror shall include pricing for all line items, as stated in the RFQ.

Reasonableness – The degree to which the offeror’s total proposed price represents a fair and reasonable price. The offeror’s total proposed price will be used to evaluate price reasonableness.

Offeror’s price quote shall be determined to be complete and reasonable in order for the offeror to be eligible for award.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (FEB 2021)

ALTERNATE I (OCT 2014)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision--

"Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

"Economically disadvantaged women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

"Forced or indentured child labor" means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or https://www.sam.gov/

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

"Highest-level owner" means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

"Immediate owner" means an entity, other than the offeror, that has direct…