Amendment_3_to_the_RFP_-_10-08-2024_0003.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

10/08/2024

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

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.: 003

CONTINUATION PAGE

This amendment modifies Section J – Attachments and Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website. This amendment also provides answers to questions received regarding this RFP. 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.

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

1. Section J: Attachments

a. The following attachment is added to this RFP:

Attachment 30 - The Study Record: PHS Human Subjects and Clinical Trials Information – Form 0925-0001 – This form must be included in the Human Subjects Protection attachment of your proposal.

The link to this form is below.

https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

b. Attachment 13 to the RFP is replaced in its entirety with the updated Form 0990-0263 - Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule) for use through June 30, 2024, instead of March 31, 2018. This form must be included in the Human Subjects Protection attachment of your proposal. The link to this form is below.

https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

2. Section J- Attachments – Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, is amended to add the following:

1. The PHS Human Subjects and Clinical Trials information is submitted as a separate pdf attachment via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. This is attached as a separate pdf attachment right under the Technical Proposal section in ECPS. The attachment entitled, “PHS Human Subject and Clinical Trials,” and all its pages are excluded from the Technical Proposal page limits. See screenshot below from eCPS.

https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://ecps.nih.gov/

RFP-NIH-NICHD-75N94024R00008

AMENDMENT NO.: 003

CONTINUATION PAGE

B. QUESTIONS AND ANSWERS:

Question 1. - Do we need to outline the Human Subjects information for each protocol?

Answer: Yes

Question 2. - Should the Human Subjects section be included as part of the technical proposal or should these be submitted on the SF424 Human Subjects forms?

Answer: The SF-424 entitled, Research Instructions for NIH and Other PHS Agencies,” is not relevant to this RFP and should not be submitted. The Human Subjects section, entitled, “PHS Human Subjects and Clinical Trials” requires the form entitled, The Study Record: PHS Human Subjects and Clinical Trials Information – Form 0925-0001 (Added as Attachment 39 in Section J to the RFP in this amendment) to be submitted. The RFP also requires submission of Attachment 13, the updated OMB No. 0990-0263 Form – Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule) for use through June 2024.

This updated form is also included in this amendment.

Question 3.- If part of the Technical proposal, are these sections excluded from the page count?

Answer: This Human Subject section is not a part of the technical proposal and is located right under the Technical Proposal in the ECPS system. The Human Subjects information is a separate pdf attachment. It is submitted as a separate pdf attachment entitled, “PHS Human Subjects and Clinical Trials.” This section on Human Subjects is excluded from the technical proposal page limits. See ECPS screenshot below.