Amendment 3-RFP NIH-NICHD-CDP-2020-2.pdf

OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

04/09/2020

4. REQUISITION/PURCHASE

REQ. NO.

N/A

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch 6710B Rockledge Drive, MSC 7000

BETHESDA, MD 20892-7000

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

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION NO.

RFP NIH-NICHD-CDP-2020-2

X

9B. DATED (SEE ITEM 11)

1/28/2020

10A. MODIFICATION OF CONTRACT/ORDER

NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in item 14. The hour and date specified for receipt of Offers 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___ copy of the amendment in your business proposal; (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 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 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.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

N/A

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 FAR 52.243-2. 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) and Contract ARTICLE B.4.

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

D.OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor __ is not, X is required to sign this document and return _1_ copy in your business proposal to the issuing office.

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

PURPOSE: To provide Reporting Requirements and Deliverables Attachments 5, 5a, and 5b of the RFP.

DUE DATE: April 28, 2020, 3:00 PM Eastern Standard Time (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

NICHD Contracts Management Branch, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ________________________________________

(Signature of Contracting Officer)

16C.DATE

SIGNED

RFP-NIH-NICHD-CDP-2020-2

AMENDMENT NO.: 03

CONTINUATION PAGE

SECTION J – LIST OF ATTACHMENTS, SOLICITATION ATTACHMENTS, is modified to add the following attachments, which are included with this amendment:

Attachment 5: Reporting Requirements and Deliverables - IDIQ Contract Attachment 5a: Reporting Requirements and Deliverables - Task Order 1 Attachment 5b: Reporting Requirements and Deliverables Sample - Task Order 2

SECTION J – LIST OF ATTACHMENTS, SOLICITATION ATTACHMENTS, Attachment 3b, page 3 (page 149 of the RFP), item E. CLOSEOUT, Paragraph 3. Is modified to replace “Attachment No. 4” with “Attachment 5b”.

Attachment 5

REPORTING REQUIREMENTS AND DELIVERABLES

Contraceptive Clinical Trials Network Male Sites

IDIQ Contract

DELIVERABLE

DUE DATE

RECIPIENTS &

NUMBER OF COPIES

SUBSEQUENT

REPORTS DUE

Evidence of IRB Review and Approval Study Protocol if Applicable

As required by task order

Electronic copy to COR and

CO

Evidence of Annual IRB Review and Approval Study Protocol

IRB-approved data collection and case report forms

Data Collection As required by task

Statistical and Clinical Coordinating Center

Data File As required by task

Statistical and Clinical Coordinating Center

Final Report and Summary of Salient Information

Annual Technical Progress Report

Annual Service Contract Act Reporting

Annually by Oct. 31st.

Submitted via www.sam.gov

Annually by Oct. 31st.

Annual Progress Report

Submitted 15 days after the end of the reporting period. A bi-annual report is not due when a final report is due.

Final Report

As required by Task

Within 10 days of the completion of the Task Order.

http://www.sam.gov/

Roster of Employees Requiring Suitability Investigations

30 days following the start date of the first Task Order award

IT Security Plan

(IT-SP)

90 days following the starting date of the first Task Order Award

FIPS 199

Assessment

30 days following the

IT Security Certification and Accreditation (IT-

SC&A)

120 days following the starting date of the first Task Order award

Reporting of New and Departed

Within 5 business days of a staffing change

Submitted within 5 days of each subsequent staffing change

Contractor- Employee Non- Disclosure Agreements

Vulnerability Scanning Reports

90 days following the

Monthly

Financial Conflict of Interest Report

Within 30 days after anniversary date of the first Task Order award

Annually

List of Employees Requiring NIH IT Security Awareness Training

As required

NIH IT Security Awareness Training

90 days following the start of the first Task Order award

Technical Reports described above shall be submitted to both the NICHD COR and Contracting Officer at the following e-mail addresses:

COR: TBD Contracting Officer: TBD

Attachment 5a

TECHNICAL REPORTING REQUIREMENTS AND DELIVERABLES

Task Order No. 1 “Core Function Activities”

The contractor is required to prepare and submit the following reports in the manner stated below:

A. Evidence of IRB Review and Approval of Protocols if Applicable If requested to obtain IRB Review of a specific Protocol, the Contractor shall provide evidence of IRB review and approval of the protocol.

B. Final Report due on the completion date of the Task Order

1) A title page containing:

a. Contract number and Project Title

b. Task Order Number

c. Period of performance being reported

d. Contractor’s name and address

e. Date of submission

2) Report shall include a summary of the work performed.

C. Technical Reports Delivery Schedule Satisfactory performance of the contract is defined as satisfactorily performing the statement of work and delivering the following items.

DELIVERABLE

DUE DATE

RECIPIENTS &

NUMBER OF

COPIES

SUBSEQUENT

REPORTS DUE

Evidence of IRB Review and Approval Study Protocol if Applicable

Electronic via e-mail to both COR and

Within 7 days of approval notice from IRB.

Final Report and Summary of Salient Information

Electronic via e-mail to both COR and

On/before the completion date of the task order contract.

Annual Service Contract Act Reporting

Annually by Oct.31.

Submitted via www.sam.gov

Annually by Oct. 31.

http://www.sam.gov/

Roster of

Requiring Suitability Investigations

30 days following the start date of the award

Electronic copy to COR and CO

IT Security Plan

(IT-SP)

90 days following the starting date of the first Task

FIPS 199

Assessment

30 days following the start date of the

IT Security Certification and Accreditation (IT-

SC&A)

120 days following the starting date of the first Task

Reporting of New and Departed

Within 5 business days of a staffing

Submitted within 5 days of each subsequent staffing

Contractor- Employee Non- Disclosure Agreements

Vulnerability Scanning Reports

90 days following the start date of the

Monthly

Financial Conflict of Interest Report

Within 30 days after anniversary date of the first

List of Employees Requiring NIH IT Security Awareness Training

As required

NIH IT Security Awareness Training

90 days following the start of the first

D. Copies of reports shall be sent to the following addresses:

NICHD COR NICHD Contracting Officer

TBD TBD

Attachment 5b

TECHNICAL REPORTING REQUIREMENTS AND DELIVERABLES

Sample Task Order No. 2 “Safety and tolerability, pharmacokinetics and pharmacodynamics of a long acting injectable progesterone analog with topical testosterone in healthy male volunteers”

The contractor shall be required to prepare and submit the following reports in the manner stated below:

A. Annual Technical Progress Report

Annually, by October 31 following commencement of enrollment, the contractor shall supply a written report showing progress of enrollment as well as the status of the inclusion of members of minority groups and their subpopulations as of each September 30 and at the completion of enrollment if earlier than September 30. The report shall be in accordance with the format below including:

1) A title page containing:

(a) Contract number and Project Title

(b) Task Order Number

(c) Period of performance being reported

(d) Contractor’s name and address

(e) Date of submission

2) Report shall include:

(a) A written report, including the number of participants screened, the number of participants enrolled, problems encountered, if any, and resolution or proposed resolution of those problems.

(b) Table of Clinical Research Populations containing number and percentage of minority groups defined by the demographic requirements of the protocol.

B. Evidence of Annual IRB Review and Approval of Study Protocol

In addition to obtaining initial IRB review and approval of the protocol and obtaining the Contracting Officer’s written notice of approval as described in the Clause entitled “Human Subjects” in Section H of the IDIQ contract, the Contractor shall provide evidence of each subsequent annual IRB review and approval of the protocol within 30 days of each annual anniversary of the Contractor’s initial IRB approval of the protocol.

C. Final Report due on the completion date of the Task Order

1) A title page as described above in section A-1.

2) A written report summarizing the work performed and the results obtained in the trial.

D. Data Collection Within 14 days of each subject visit, the Contractor shall provide to the Statistical and Clinical Coordinating Center all case report forms required under the protocol.

Attachment 5b

E. Data File

On or before the completion date of the Task Order, the Contractor shall provide to the Statistical and Clinical Coordinating Center all data obtained and/or generated under this contract, except patient identifiers.

F. Technical Reports Delivery Schedule

Satisfactory performance of the contract is defined as satisfactorily performing the statement of work and delivering the following items.

Ite m

Type of Deliverable

Recipients & Number of Copies

Reports Due

1. Annual Technical

Progress Report

Within 30 days after the Anniversary Date of the Task Order. An annual report is not due when the Final Report is due.

Evidence of Annual IRB Review and Approval Study Protocol

Due within 30 days of each annual anniversary of the Contractor’s initial IRB approval of the Protocol.

3. Final Report and Summary of Salient Results

On/before the completion date of the contract.

G. Other Reports Delivery Schedule Satisfactory performance of the contract is defined as satisfactorily performing the statement of work and delivering the following items.

Item Type of Deliverable

Recipients & Number of Copies

Reports Due

1. IRB-approved data collection and case report forms

Six months after the effective date of the contract.

2. Data Collection Statistical and Clinical Coordinating Center

Within two weeks from time of collection.

3 Data File Statistical and Clinical Coordinating Center

On or before the completion date of the task.

H. Copies of reports shall be sent to the following addresses:

NICHD COR: TBD

NICHD Contracting Officer: TBD