7591021R00001A-Amendment 1.pdf

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

1 5

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

To All Contractors 75N91021R00001A

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

0001 03/29/2021

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

National Institutes of Health National Cancer Institute Frederick, MD 21701

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 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or electronic communication 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 you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

IT MODIFIES THE CONTRACT/ORDER NUMBER 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

NUMBER IN ITEM 10A.

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

The purpose of this amendment is to provide Government responses to vendor/offeror questions regarding the Request for Proposal (RFP) via Attachment 18-Responses to Vendor Questions, which is incorporated into the RFP, and to Section J, List of Attachments. All other terms, conditions and provisions remain the same.

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)

Michael Collins / Contracting Officer

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

3/29/2021 Previous edition unusable STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

7591021R00001A - Attachment 18 - Responses to Vendor Questions

The following are questions received, and Government responses to questions received for Solicitation/Request for Proposal 7591021R0001A.

RFP or

SOW

Section

RFP or

SOW

Page

Number

Question Government Response

RFP Pages 11 and 59

Please confirm that labor for information technology (IT) systems support should be included in the budget for compliance with information and/or physical security.

Yes labor for IT systems should be included in budget for information and/or physical security.

RFP Pages 12 and 61

The RFP requires an Independent Assessment of IT system due 90 days after contract award by a third party. Would a self-assessment in lieu of a third party be acceptable if the respondent already has an Authorization to Operate from another USG agency, and taking into account the Level 1: Non-Sensitive designation?

The information, as defined in the RFP section is not “government information and information systems” and instead is predominantly a service requirement until after a contractor uploads it to the NCCIH SharePoint. The RFP/SOW does not require the contractor to design, develop, operate, or maintain a system to contain government data.

The requirement predominantly may require a contractor to work on a GFE laptop and plug into the NIH network and submit a non-disclosure agreement prior to doing so. Therefore, the self-assessment would not be necessary unless the aforementioned criteria would be required.

RFP Page 55

Section L.2.a.4 states that the technical proposal “must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the offeror's understanding of the project may be evaluated (See SECTION J, Attachment entitled, TECHNICAL PROPOSAL COST

SUMMARY”.

See Attachment 9 of the RFP as cost/price template. It is the same as described.

7591021R00001A - Attachment 18 - Responses to Vendor Questions Page 2 of 5

No document titled “Technical Proposal Cost Summary” is listed in Section J of the RFP or included as an attachment. Please provide a template for the Technical Proposal Cost Summary as an attachment if it is required.

See Attachment 9 of the RFP as cost/price template. It is the same as described.

RFP Pages 58 and 90

Please clarify the past performance requirements.

Are respondents required to include the information outlined on page 90 for all related contracts including contracts completed in the last 3 years? (Reference text is below)

Yes.

Page 58 of the Request for Proposal (RFP) indicates, “A list of the last five (5) contracts completed during the past Three years and ALL CONTRACTS AWARDED currently being performed that are similar in nature to the solicitation work scope.”

This is a listing of the Offeror's last 5 contracts completed within the last 3 years. This list may must include of all other contracts that were awarded that are currently being performed. If awarded prior to three years ago, currently performing contracts must be included in this listing which are similar in nature to the solicitation work scope, and may (if some are still performing) exceed five in total.

Page 90 of the RFP indicates, “Pertinent contracts is defined as listing of each related contract completed within the last three years or currently in process. The listing should include: 1) the contract number; 2) contracting agency; 3) contract dollar value; 4) dates contract began and ended (or ends); 5) description of contract work; 6) explanation of relevance of work to the RFP; 7) actual delivery and cost performance versus delivery and cost agreed to in the contract(s).

For award fee contracts separately state in dollars the base fee and award fee available and the award fee actually received. The same type of organizational experience and past performance data should be submitted.”

This is a listing of only the last 3 years related contracts, and may exceed three years if they are still being performed but awarded over 3 years ago.

RFP Page 75 Resumes of all key personnel are required. Please confirm if resumes for all staff listed in the proposal are also required.

Only resumes for key personnel are required.

SOW and

RFP

SOW

page

7;RFP

Page 17 of the RFP states that final site visits reports will be distributed to the site within 2 business days of the Contracting Officer’s Representatives (COR) comments, and page 7 of the Statement of Work

Final site visit reports should be distributed to the site within 2 business days of the Contracting Officer's

7591021R00001A - Attachment 18 - Responses to Vendor Questions Page 3 of 5

(SOW) states within 5 business days of the COR comments. Please clarify the timeline.

Representatives (COR) comments.

SOW Pages 14 and 15

Section F of the SOW references support for Data and Safety Monitoring Board (DSMB) and other meetings.

For budgeting purposes, is there an estimate of the number of meetings that will be supported? In addition, will the meetings be in person or remote?

Finally, if held in person, will the meetings be local to Rockville, Maryland or will they be geographically distant?

a) We anticipate 5-7 DSMB meetings per year. DSMBs are comprised of 4-8 members.

Not all members will be eligible or claim honoraria. B) 1-2 in-person meetings per year with one overnight stay.

4-6 members traveling per in-person meeting. C) 2-4 independently prepared materials per year.

SOW

Page 15, Section F.1.e.1

Should labor hours for statistical support be included in the budget as described in the SOW?

Labor hours should be included as necessary, however labor that is already accounted for otherwise or rolled into indirect costs should not be provided as they are already in indirect costs.

Please confirm the following required attachments are exempt from the 100-page Technical Proposal page limit: SOPs List, Training Plan, QA/QC Plan, Integrated Master Project Plan, Transition Plan, Section 508 VPATs, 3-page (maximum) CVs for Key Personnel, Summary of Related Activities, and Technical Proposal Cost Summary

Resumes are not included in page limits, though the stated limits for each Resume remain for any that are stated. SOPs, QA/QC Integrated Master Project Plan, Transition, and 508 information may not cause the Technical Volume to exceed 100 pages in total.

RFP Pg 76

1. RFP Page 76 states that less than five (5) visits/year to international sites (none anticipated overseas). a.

Please confirm if “international” means Latin America and North America (outside of USA). If not, please specify the locations.b. For uniform costing purposes, what proportion of the visits should we assume will be in person vs remote?

a) At this time, international sites refers to countries in North America and Latin America. B) At this time due to the COVID-19 pandemic, it is assumed that 75% of site visits will be remote and 25% will be in-person.

SOW F.1 Pg 14

Attachment 3, SOW, Section F.1 Page 14, Coordinate and provide technical and administrative support for the activities of the NCCIH established Clinical Studies oversight entities, including Data and Safety Monitoring Boards (DSMBs) Meetings, Steering Committee 'Meetings, and designated NCCIH Investigator Meetings.

a. For costing purposes, how many DSMB meetings would we support per year?

b. How many participants/members, how many travel days, how many members will receive honorarium?

c. For costing purposes, please provide assumed numbers of items/materials needing to be

a) We anticipate 5-7 DSMB meetings per year. DSMBs are comprised of 4-8 members.

Not all members will be eligible or claim honoraria. B) 1-2 in-person meetings per year with one overnight stay.

4-6 members traveling per in-person meeting. C) 2-4 independently prepared materials per year.

7591021R00001A - Attachment 18 - Responses to Vendor Questions Page 4 of 5

“independently prepared”(item b): for example, concept proposals and draft protocols.

SOW Sec G

INITIAL AND FINAL TRANSITIONS–– Please identified the systems that may need to be transitioned, or if just documentation?

Documentation needs to be transitioned and access to NCCIH SharePoint system.

SOW & RFP

SOW

2.C.2 Pg

9 & RFP

Pg 94 Sec M.4.3.A.ii

4. Attachment 3. SOW, Section 2.C.2. pg. 9––Please clarify the Supervisory Site Monitor is the same as the Lead Site Monitor (Section M.4.3.A.ii of RFP pg. 94).

The Supervisory Site Monitor is the same as the Lead Site Monitor.

7591021R00001A - Attachment 18 - Responses to Vendor Questions Page 5 of 5