Amendment_1_to_RFP_75N94024R00008_9-11-24_0001.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

09/11/2024

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: Provide Amendment #1 as part of the RFP to: 1. Revise Attachment #3, 2. Replace Attachment #7 and 3.

Provide an answer to a question received.

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.: 001

CONTINUATION PAGE

A. As a result of this amendment, RFP No. 75N94024R00008, is revised as follows:

1. Attachment #3, Page #234, OVERALL BASIC IDIQ STATEMENT OF WORK, under section III (B) (10) entitled, “Additional NIH Requirement”, is revised to read as follows:

10) Additional NIH Requirement is revised to read as follows:

a. Prime Contractors are encouraged to seek out the Eligible Organizations listed below as part of the clinical network as clinical sites. The organizations listed below are also eligible to respond to this acquisition as prime contractors.

• Historically Black Colleges and Universities (HBCUs)

• Hispanic-serving Institutions

• Tribally Controlled Colleges and Universities (TCCUs)

• Alaska Native and Native Hawaiian Serving Institutions

• Asian American Native American Pacific Islander Serving

Institutions (AANAPISIs).

2. Attachment #7 – Additional Technical and Business Proposal Instructions and Uniform Assumptions is replaced in its entirety with the attached “Attachment 7 dated 9-10-24 - Additional Technical and Business Proposal Instructions and Uniform Assumptions.” (See Attachment)

B. In addition to above, this amendment also provides an answer to a question received regarding this RFP. This response is provided for information only as guidance to potential offerors and do not supersede any terms of the RFP and does not revise or become part of this RFP.

Question: Per the RFP on page 234 “Eligible Institutions”

10) Additional NIH Requirement

a. Eligible Organizations Higher Education Institutions

• Public/State Controlled Institutions of Higher Education

• Private Institutions of Higher Education

Does this mean that the RFP is limited to responses from Higher Education Institutions only and that Clinical Research Organizations are not able to submit a proposal?

Answer: No. Any type of organization is allowed to submit a proposal in response to this solicitation. This section of the RFP has been revised in item #1 above.

RFP-75N24024R00008 ATTACHMENT 7

Additional Technical and Business Proposal Instructions and Uniform Cost Assumptions revised 9-10-24

In addition to the format requirements for the Business Proposal that are contained in Section L of the solicitation, the information presented here intends to provide uniform cost assumptions and business clarifications to assist in the preparation of your proposal.

A. General Contract Assumptions

1. Most clinical testing will be conducted on four (4) age groups for the clinical studies.

2. Phase 3 studies (large scale efficacy trials) are unlikely, but possible.

3. Formulations:

a. A new research formulation of a commercially available drug, likely a liquid formulation for the pediatric clinical trials, may be required in some instances for the pediatric clinical trials conducted under the PTN.

b. The formulation must be produced according to FDA’s Good Manufacturing Practice (GMP) standards.

B. Task Order 1 (Core Function Activities) Assumptions

1. Estimate of Effort: The Government considers the effort to be approximately 364% annual effort per year. The information is provided for guidance only and is not to be considered restrictive.

2. Travel Assumptions: Assume one trip per year for seven people to attend a one-day meeting in Bethesda, MD.

3. Offerors should assume the following tasks will be initiated during the life of Task Order No. 1:

Types of Clinical Studies – NICHD anticipates that individual TOs for Clinical Studies will be written for one of the following types of trials during performance of this Contract:

a. Phase 1 studies

1) Phase 1 studies may need to be performed prior to the Phase 2 study to determine the correct dose for the larger Phase 2 study.

2) The Phase 1 studies will be designed with either a sparse or dense PK sampling, and with pertinent safety data collection.

b. Phase 2 studies

1) Phase 2 studies are small efficacy and safety studies (less than 200 patients), and generally include PK data collection as well.

RFP-75N24024R00008 ATTACHMENT 7

2) The Phase 2 studies may use the dose determined from the Phase 1 PK/dose-ranging study.

c. Phase 3 studies

1) Phase 3 studies are large efficacy and safety studies (more than 200 patients), and generally include PK data collection as well.

2) Phase 3 studies may use the dose determined from Phase 2 studies.

C. Task Order 2 – “Decentralized Clinical Trials” – Please include a concept proposal for this study and not a full protocol. The concept should include the rationale and hypothesis for the study; a proposed design of the study; the proposed study population and potential outcomes of the study; and an estimation for the number of participants required for the study.

D. Task Order 3 - Pediatric Opportunistic Pharmacology Trials

NOTE

For evaluation purposes, offerors are required to develop a draft protocol for the Task Order 3 study, entitled, “Pediatric Opportunistic Pharmacology Trials,” and submit it with their proposal. This requirement includes the following:

1. The Offeror must provide a summary of successful and failed pediatric clinical trials (as well as FDA label updates if applicable) for pediatric opportunistic pharmacology trials.

2. A draft protocol shall be developed including the following:

a. Assume that the number of pediatric patients needed to achieve statistical significance

b. Determine the number of sites required for adequate recruitment.

c. Develop a screening process for site recruitment.

d. Develop inclusion/exclusion criteria for the study.

e. Develop a PK study design, employing a timed sampling scheme to determine the

PK.

E. GOVERNMENT FURNISHED PROPERTY

The Government will furnish the successful offeror a System Eye Tracking Portal -

$16,550 – Acquisition Cost from the predecessor contract.