Amendment_4_to_the_RFP_-_10-11-2024_0004.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

10/11/2024

4. REQUISITION/PURCHASE

REQ. NO.

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

BETHESDA MD 20892

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

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION

NO.

RFP 75N94024R00008 X

9B. DATED (SEE ITEM 11)

9/4/2024

10A. MODIFICATION OF

CONTRACT/ORDER NO.

CODE

FACILITY CODE

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.

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)

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 answers to questions received and to modify the Statement of Work of Task Order 2 – Decentralized Clinical Trials.

DUE DATE: November 4, 2024, 4:30 PM Local Time (Eastern Standard Time (EST) (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

Elizabeth Osinski

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-75N94024R00008

AMENDMENT NO.: 004 CONTINUATION PAGE Page 2 of 4

As a result of this amendment, RFP No. 75N94024R00008, Attachment 5 – Statement of Work, Task Order 2 entitled, “Decentralized Clinical Trials,” is revised as follows:

SECTION D -Study Requirements and Timeline, on pages 3, 4 and 5 as reprinted below is deleted in its entirety from this Task Order 2 Statement of Work.

Phase 1A - Preparation for Implementation (3 Months)

• The finalization of the protocol will have included input from the, BPCA-DCC, NICHD, and any other requested Subcontractors. The final version of the protocol shall be provided to the BPCA-DCC with a copy to the NICHD Contracting Officer Representative (COR).

• Identify and sub-contract with selected study sites.

Phase 1B - Preparation for Implementation (3 Months)

3. Develop and implement the Manual Operating Procedures (MOP) for the Study which details the relationships and responsibilities among the DCC, the PTN and all subcontractors (if applicable). Review and finalize all forms necessary for protocol implementation -including Informed Consent Forms and Assent Forms, case report forms, standards of operating procedures, etc.

4. Obtain Internal Review Board (IRB(s)) approvals for the final Food and Drug Administration (FDA)approved protocol, demonstrate Health Insurance Portability and Accountability Act (HIPPA) compliance, and any other requirements as specified by the Contractor's agency, department, and/or State.

5. Contractor shall be accessible for periodic site visits by personnel from the BPCA-DCC and the NICHD to discuss progress, problems and to review data.

4. Phase 2 - Implementation (12 Months)

• Conduct an Investigators’ meeting to include members of the Contractor’s (subcontractors, if applicable) staff, the NICHD COR, and appropriate representatives from the BPCA-DCC. This meeting will be conducted prior to patient enrollment.

• Obtain written parental or legal guardian permission to participate in a clinical trial.

• Prior to transmission of data with data identifiers to the BPCA-DCC, written authorization from parents or legal guardians must be obtained.

• Recruit and retain sufficient numbers of patients to complete the requirements of the statement of work.

ii) Develop a MOP that includes performance standards and elements for the PODS Center and subcontractor site (s).

iii) Demonstrate that the MOP includes a means to measure and follow the quality assurance procedures for the centers and/or labs, and implement the protocol- specific monitoring plans developed by the BPCA-DCC.

iv) Review, coordinate, and adopt the Case Report Forms that have been developed by the BPCA-DCC.

AMENDMENT NO.: 004 CONTINUATION PAGE Page 3 of 4

e. Provide the NICHD with biannual and annual reports of the activities of the clinical trial. Copies of the information shall also be provided to the BPCA-

DCC.

f. Comply with NIH and FDA policies and regulations concerning clinical trials. Follow the quality assurance procedures and implement the protocol-specific monitoring plans developed by the BPCA-DCC.

g. Provide the BPCA-DCC with all the required data elements included in the information system and standardized computer based data collection system, i.e., the NIH Clinical Database. The Contractor shall provide information requested by the BPCA-DCC and/or NICHD to assure regulatory compliance for research activities.

h. Respond to all inquiries from the BPCA-DCC regarding problems with the data and achieve resolution of these problems.

i. The Contractor shall meet with the NICHD Program and Contracting Staff a minimum of once a year to review progress of the study. This meeting may be included in one of the mandatory meetings listed previously; however, additional meetings may be added at the discretion of the COR and/or CO.

j. The Contractor shall conduct biannual performance evaluations of all subcontractor(s) sites, if applicable, and submit the results to the COR and CO. This information may be included in the Contractor’s biannual report to the NICHD. Monitoring of the subcontract sites shall be done using a graded plan by the PTN.

i. Develop a problem-resolution policy and process for the study related activities that includes policies for underperformance.

ii. Monitor progress of research studies at the study site(s) and resolve any issues.

iii. Recommend, as necessary, additional study sites.

iv. Review, coordinate, and adopt the BPCA-DCC’s Data Management

System and resolve issues, as needed.

k. The Contractor shall report all adverse drug events to the BPCA-DCC. The BPCA- DCC shall be notified of all serious adverse events within 24 hours in accordance with the FDA (Code of Federal Regulations). The PIs shall be available for questions regarding serious adverse events.

4. Phase 3 - Close down (6 Months)

a. Finalize the database and all supporting documentation and forward (i.e., cleaned and edited) to the COR upon completion of the study.

b. Provide the NICHD COR and CO with a final report of the activities of the clinical trial.

AMENDMENT NO.: 004 CONTINUATION PAGE Page 4 of 4

B. QUESTIONS AND ANSWERS:

These answers are provided for information only as guidance to potential offerors and do not supersede any terms of the RFP and do not revise or become part of this

RFP.

• Question 1. - Per the RFP for Task Order 2, we are to include a concept proposal for this study and not a full protocol. Should the budget reflect either 1) the concept proposal development task or 2) the concept proposal development task plus the cost of the implementation and close of the full draft protocol?

• Answer: As stated in Amendment 1, only the concept proposal should be prepared. Therefore, the Statement of Work is amended to delete Section D above. The budget should reflect the costs for the concept proposal development only.

• Question 2. - If the cost of the implementation and close of the full draft protocol is required, is the PHS Human Subjects and Clinical Trials Information form required for Task Order 2?

• Answer: No, because this is only a concept proposal, the PHS Human Subjects and Clinical Trial Information form is not required.