CCTN RFP Amendment 3 12-11-2019.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

12/11/2019

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

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 NIH-NICHD-CDP-2020-1

X

9B. DATED (SEE ITEM 11)

9/24/2019

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)

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 clarifications based on inquiries received regarding RFP NIH-NICHD-CDP-2020-1 entitled, “Contraceptive Development Program NICHD Clinical Trials Network Female Sites”.

DUE DATE: January 8, 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

Deborah Brock 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-2020-1

AMENDMENT NO.: 0003

CONTINUATION PAGE

Below are the answers to questions received regarding this RFP, please note that individual questions may have been combined or reworded. The responses to inquiries are as follows:

1. Question: What do we need to include in our proposal to satisfy the section 508 assessment?

Response: Offerors shall complete the template found in Section J, Attachment 12 link on page 70 and submit with their technical proposal. Follow the guidance in Section M – Evaluation Factors for Award, 7.

Evaluation of Electronic and Information Technology Accessibility – Section 508 found on page 132 of the RFP. The Section 508 Accessibility Standards applicable to this solicitation can be found on page 116 of this RFP. For more information on Section 508 Accessibility Standards please visit the following link:

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards

2. Question: We logged into the electronic Contract Proposal Submission (eCPS) to familiarize ourselves with the submission platform and noticed that the PHS Human Subjects and Clinical Trials Document pdf is listed as a required file in the eCPS, though, Amendment #2 says that it is not required for this submission.

Response: Correct. The PHS Human Subjects and Clinical Trials Form/Document is currently listed on the eCPS as a requirement for submission; however, the section will be removed from the proposal system.

For now, please disregard. We encourage offerors to access eCPS and become familiar with the system prior the submission deadline.

3. Question: Is there an NICHD-approved protocol that can be referenced when putting together technical and business proposals for sample Task Order 2?

Response: Offerors can find an example of a CCTN phase II protocol on https://clinicaltrials.gov/. Please refer to clinical trial record number NCT03432416: https://clinicaltrials.gov/ct2/show/NCT03432416. See page 116 of the RFP for business proposal instructions.

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards https://clinicaltrials.gov/ https://clinicaltrials.gov/ct2/show/NCT03432416