00018_Amend_1.pdf

OMB No 0990-0115

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 4

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

0001 July 8, 2015 N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6)

CODE N/A

HHS/OS/ASPR/AMCG

200 C Street SW Washington, DC 20024

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) () 9A. AMENDMENT OF SOLICITATION NO.

TO ALL POTENTIAL OFFERORS

15-100-SOL-00018

9B. DATED (SEE ITEM 11)

June 26, 2015

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

() A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET

FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PURPOSE:

1. Revise Section B.2.1. and B.2.2. (CLIN 4 is an Option Quantity and CLIN 2 is part of the Base Funding)

2. Revise L.3 to clarify where to submit Mandatory Criteria.

3. Revise Section L.4. to delete the page limit total for business proposals and define a “major subcontractor”.

4. Provide a word version of the solicitation for access to the attachments.

Deadline for Questions: July 6, 2015; 1PM (Local Time, Washington DC) (Unchanged)

Proposal Due Date: July 27, 2015; 1PM (Local Time, Washington DC) (Unchanged)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Christopher Scott, Contracting Officer

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY _____________________________________________

(Signature of Contracting Officer)

July 8, 2015

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

FAR (48 CFR) 53.243

.2.1. ESTIMATED COST AND FIXED FEE

Base Period Cost Reimbursement CLINs

Item Supplies/Services Estimated Cost

Fixed Fee

Cost + Fixed Fee (CPFF)

0001 (Base) Licensure, approval, and clearance of product through the FDA

TBD TBD TBD

0004 (Option Quantity)

Pediatric Studies (This is an option that may or may not be exercised during the base period for expansion of the label indication with guidance from the FDA)

TBD TBD TBD

B.2.2. FIRM FIXED PRICE

Base Period Fixed Price CLINs

Item Supplies/Services Units (# of Product)

Unit Price ($)

Total ($)

0002 (Base) Initial purchase, storage, and delivery of product

TBD TBD TBD

(Option Quantity)

Surge Capacity – Additional procurement of product (This is an option that may or may not be exercised during the base period due to product demand or unforeseen medical emergencies)

TBD TBD TBD

Item Supplies/Services Total ($)

(Option Quantity)

Phase IV post marketing commitments /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as established by the FDA)

TBD

B.3. ADVANCE UNDERSTANDINGS

The final contract may contain advance understandings between the Government and the Contractor. Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost will be included in this Section if the Contracting Officer has granted his/her approval prior to contract award.

B.4. PROVISIONS TO APPLICABLE COSTS

This section prohibits or restricts the use of contract funds which includes the following items (costs unallowable unless otherwise approved by the Contracting Officer):

a) Acquisition, by purchase or lease, of any interest in real property;

b) Rearrangement or alteration of facilities;

c) Purchase of lease of any item of general purpose office furniture or office equipment regardless of dollar value;

d) Accountable Government Property;

e) Overtime

f) General scientific meetings/conferences;

g) Travel costs including foreign travel;

h) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);

L.3.1.1. Technical Proposal – Components

(1) Section 1: Cover Page (does not count towards the 75 page total limit)

Proposal Title Page including RFP title, number, name of organization and DUNs number.

Table of Contents

Government notice for handling of proposals

(2) Section 2: Technical Proposal Overview Provide a brief overview of the Technical Proposal, including the following:

A. A brief description of activities to be performed by the Contractor and all proposed subcontractors to expand capabilities (example: path support, surgical implants, behavior SMEs), including identification of all proposed subcontractors and a list of key personnel for the Contractor and the proposed subcontractors with degrees, titles and role within the project.

B. Contractors shall describe the activities to be subcontracted, the method and level of integration between the prime and any proposed subcontractor(s), and the expected advantages of such an approach. A summary of staff expertise including the total number trained number available to be assigned to this contract for the Contractor(s) and all proposed subcontractor(s), and the total number of additional staff to be hired and trained.

(3) Section 3: Technical Evaluation The Statement of Objectives, included as SECTION C, provides the Government’s overall objectives, and the Contractor’s required support to achieve those objectives. The proposed SOW shall provide a detailed plan indicating how each aspect of the SOO shall be accomplished. This plan shall be in as much detail as considered necessary to fully explain the proposed technical approach or method. The proposal shall reflect a clear understanding of the nature of the work being undertaken. The proposal must include information on how the project is to be organized, staffed, and managed. This information shall demonstrate your understanding of important events or tasks and their management. You shall explain how the management and coordination of consultant and/or sub-contractor efforts will be accomplished. The Contractor shall use the SOO, together with other applicable portions of the RFP as a basis for preparing a proposed statement of work (SOW) including the Work Breakdown Structure (WBS), Project Gantt, Contract Milestones and Deliverables table with appropriate success and go/no-go decision points as necessary.

Contractor(s) can refer to the guidance provided under: http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx

The SOW shall be submitted as part of the technical proposal and will be incorporated into the contract at award.

Proposals will be technically evaluated in accordance with Section M – Evaluation Factors for Award of this solicitation.

L.3.2. Appendices to Technical Proposal

Items below can be revised during negotiations with the successful Contractor(s) and will be incorporated into the contract.

1) The Contractor shall describe their Security Plan, which covers physical, personnel, transport mechanisms and staffing, and Information Technology (IT) infrastructure security. (Attachment #16)

2) Curriculum vitae of key personnel. There shall be enough detail to ensure the USG that key individuals will be able to perform the work described in the Technical Proposal. The resumes shall contain information on education, background, recent experience, and specific or technical accomplishments, as they pertain to their ability to support the objectives of this project. The approximate percentage of time each individual will be available for this project must be stated. The proposed staff hours of each individual shall be allocated against each project task or subtask.

http://www.phe.gov/about/amcg/toolkit/Pages/default.aspx

L.4.3. Business Proposal – Other Information

(1) Commitment of Public Funds

The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed procurement. Any other commitment, either explicit or implied, is invalid.

(2) Communications Prior to Contract Award

Contractor(s) shall direct all communications to the attention of the Contract Specialist or Contracting Officer cited on the face page of this RFP. Communications with any other Government official regarding this RFP is strictly prohibited, and may disqualify your proposal for further consideration.

(3) Late Proposals and Revisions

FAR 52.215-1 (Jan 2014) and HHSAR 352.215-70 (Jan 2006) is applicable to this solicitation.

(4) Alternate Proposals

The Contractor(s) may, at its discretion, submit alternate proposals or proposals that deviate from this solicitation’s requirements; provided that the Contractor(s) also submits a proposal for performance of the work, as specified in the SOO. Alternate proposals may be considered if performance would be improved or not compromised, and if they are in the best interest of the Government. Alternate proposals, or deviations from any requirements of this RFP, must be clearly identified.

(5) Past performance information

Contractor(s) shall submit the following information as part of their business proposal for both the Contractor and proposed major subcontractors. For the purposes of this solicitation, a “major subcontract” is defined as a subcontract in excess of $500,000.

The Contractor(s) shall provide a list of the last five (5) contracts completed during the past three years and all contracts currently being performed that are similar in nature to the solicitation work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers. Any previous activities with BARDA must be included in the submitted past performance list. Contractor(s) that are newly formed entities without prior contracts shall list contracts and subcontracts as required above for all key personnel.

Include the following information for each contract or subcontract listed:

(a) Name of Contracting Organization

(b) Contract Number

(c) Total Contract Value

(d) Description of Requirement

(e) Contracting Officer’s name, email and telephone number

(f) Program Manager’s name, email and telephone number

(g) Statement from Contractor as to why this contract is relevant to this project.