75N91019R00002_Amendment_001_Final.pdf

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 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 DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your 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 date specified.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

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

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

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

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.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

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

CHECK ONE 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)

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

Jame Chang, Contracting Officer

National Cancer Institute Office of Acquisitions 9609 Medical Center Drive Bethesda, MD 20892-9705

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION

NO.

75N91019R00002

01/29/2019

9B. DATED (SEE ITEM 11)

01/17/2019

01/29/2019

The purpose of this amendment is to: 1) Provide responses to questions received; and 2) Revise Section J - Attachment 1 and Attachment 2.

Due Date for Additional Questions: January 24, 2019, 2:00PM Eastern (Unchanged) Proposal Due Date: February 19, 2019, 12:00PM Eastern (Unchanged)

The changes referenced above are attached.

RFP No: 75N91019R00002 Amendment 0001

RFP: 75N91019R00002

Amendment 0001

I. Questions and Answers:

• Q1: In addition to the items stated in the RFP as excluded from the page count, please consider also excluding the following: Technical Proposal Cost Summary, Summary of Related Activities, Draft Continuing Education Plan, Draft Quality Control Plan, and Draft Project Management Plan.

NCI Response: This has been taken into consideration and the Technical Proposal Cost Summary, Summary of Related Activities, Draft Continuing Education Plan, Draft Quality Control Plan, and Draft Project Management Plan are excluded from the page count.

• Q2: Article 5B, Advance Understanding on p. 6 of the RFP: During actual performance of the contract, does the 2.4% annual escalation apply to overall direct labor cost or does it apply to each project staff individually?

NCI Response: The 2.4% annual escalation applies to each project staff individually.

• Q3: Article 5B, Advance Understanding on p. 6 of the RFP: Will the government allow 3% annual labor escalation for this proposal?

NCI Response: The Government will only permit a 2.4% annual escalation. While we understand Offerors have to ensure they are externally competitive, the weighted average annual change of the Consumer Price Index for the maximum period of performance of the contract is calculated at 2.4%. This by no means limits the compensation Offerors are able to provide its employees, only the amount reimbursable under the contract.

• Q4: The notice of intent form in the list of attachments is for a different requirement and there is no link for this on the NCI OA website, please address.

NCI Response: Unfortunately, the proposal intent functionality is currently not functional. If a notice of intent has yet to be submitted electronically via email, please feel free to submit a notice of intent electronically to jame.chang@nih.gov.

II. Revisions to Sections of the RFP:

Page 88 – Additional Technical Proposal Instructions: the following paragraphs under “IT Support Information” are removed and replaced with the following:

Deleted:

• A restricted-access website is maintained by the Contractor to include all study-related documents and correspondence associated with a CIRB review. Local institution staff can access the website to obtain the documents. The public website is located at the following URL www.ncicirb.org.

mailto:jame.chang@nih.gov https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ncicirb.org&data=02%7C01%7Crma%40emmes.com%7C4b14057993c54363f94d08d6808c5c8d%7C4aedf6ad32c04bb6b6bcaf5597447e81%7C0%7C0%7C636837737786293016&sdata=nb6rcrxnq67TSi1BHOXLcVsZTRIaXn6a6tcE4%2Fv3%2Bno%3D&reserved=0

RFP No: 75N91019R00002 Amendment 0001

Replaced With:

Study review documentation is housed on ctsu.org. Older documentation is stored at ncicirb.org; and this portion of the website is not viewable by the public.

Deleted:

• CIRB institution enrollment data - The incumbent contractor utilizes a proprietary IT system EMMES Advantage EDCSM to collect, track and maintain institutional CIRB participation and enrollment data.

To facilitate a smooth transition, the Contractor shall procure a one-year license, including hosting and maintenance, and 500 hours/yr of consulting services from EMMES for Advantage EDC ( https://secure.emmes.com/emmesweb/products/advantage). All custom code, web-services linking Advantage EDC to other NCI IT systems, and CIRB data shall be transferred from the incumbent to the successful awardee.

Replaced With:

• CIRB institution enrollment data – The RUMS/RSS system is used to collect, track and maintain institutional CIRB participation and enrollment data. The CIRB Roster is maintained in RUMS/RSS in addition to the worksheets in IRBManager. RUMS was developed by the CTSU Contractor and is a Government owned product. There are no costs associated with its use by the CIRB contractor. It will be provided by the Government for the CIRB contractor’s use.

Section J – List of Attachments

Attachment 1: Packaging and Delivery of Proposal (Non R & D) is hereby deleted in its entirely and replaced in this amendment.

Attachment 2: Proposal Intent Responses Sheet is hereby deleted in entirely and replaced with the following:

“Please submit notices of intent electronically to jame.chang@nih.gov”.

https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsecure.emmes.com%2Femmesweb%2Fproducts%2Fadvantage&data=02%7C01%7Crma%40emmes.com%7C4b14057993c54363f94d08d6808c5c8d%7C4aedf6ad32c04bb6b6bcaf5597447e81%7C0%7C0%7C636837737786293016&sdata=u8XSoAffzAx9okL7vtfVGmz2dZFPAi943BgQCrzCYN8%3D&reserved=0 mailto:jame.chang@nih.gov

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

75N91019R00002 – Amendment 1 Page 1 of 2

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with

FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition.

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel

Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of

Proposed Estimated Costs (plus Fee) with Excel Spreadsheet”

(http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

75N91019R00002 – Amendment 1 Page 2 of 2

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf

Business Proposal: XYZ Company_NIHAI2012001_Business.pdf

Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed 150 pages.

2. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

c. The Technical Proposal Cost Summary, Summary of Related Activities, Draft

Continuing Education Plan, Draft Quality Control Plan, and Draft Project

Management Plan

3. Each Curriculum Vitae (CV) shall not exceed 6 pages.

4. Pages exceeding limitations will be removed from the proposal and will not be considered.