CCTN RFP Amendment 4 12-26-19.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

12/26/2019

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” and amend Attachment 1 of the

RFP.

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 ________________________________________

16C.DATE

SIGNED

RFP-NIH-NICHD-CDP-2020-1

AMENDMENT NO.: 0004

CONTINUATION PAGE

(Signature of Contracting Officer)

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: Human Subjects on page 99 of the RFP says: “IMPORTANT NOTE TO OFFERORS:

The following subparagraphs shall be addressed, as applicable, in a SEPARATE FILE of the Technical Proposal entitled, “HUMAN SUBJECTS.” It is our understanding that the Technical Proposal will be one file uploaded to the eCPS website, so how are we supposed to include a separate file for this section? Or is this information supposed to be included as an attachment?

Response: The “Human Subjects” Section shall be included in the IDIQ technical proposal.

2. Question: Do we need to have a written section in the technical proposal addressing all of the items in these pages or do we instead complete the PHS Human Subjects and Clinical Trials Information Form with its related Human Subject Study Record?

Response: A written section shall be included with a separate heading within the Technical Proposal entitled, “HUMAN SUBJECTS.” Please see Section M (page 128): The reviewers will evaluate the proposal with regard to four issues: Risks to Human Subjects, Adequacy of Protection Against Risks, Potential Benefits of the Proposed Research to the Subjects and Others, and Importance of the Knowledge to be Gained. Based on the response to this criterion, this section of the proposal may be rated "unacceptable" (i.e., concerns are identified as to the protections described against risk to human subjects or no discussion is found regarding protections against risk to human subjects) or "acceptable." If the reviewers find that this portion of the proposal is "unacceptable" they will provide a narrative supporting their finding. Also, please refer to pages 99-108 of the RFP for additional information. Please note that the PHS Human Subjects and Clinical Trials Information form is not required at this time. (See RFP Amendment 2, Questions/Responses #10 and #11).

3. Question: Do we need to complete the PHS Human Subjects form?

Response: The PHS Human Subjects and Clinical Trials Information form is not required since the study under Sample Task Order 2 will not be initiated at this time. (See RFP Amendment 2, Questions/Responses 10 and #11).

4. Question: Will the human subjects section count towards to the page limits of the Technical proposal?

Response: No. Please see revised Attachment 1 on the following page.

RFP-NIH-NICHD-CDP-2020-1

AMENDMENT NO.: 0004

CONTINUATION PAGE

1. Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic

Contract Proposal Submission (eCPS) Website, B. Page limitation, is hereby revised as follows:

B. Page limitations:

TECHNICAL PROPOSAL BUSINESS PROPOSAL

The offeror must submit one (1) electronic PDF file for the Technical Proposal with three (3) sections:

1. IDIQ

2. Task Order 1

3. Sample Task Order 2

**The proposal should not exceed 45 pages including all three sections.

The offeror must submit one (1) electronic PDF file for the Business Proposal* with two (2) sections:

1. Task Order 1

2. Sample Task Order 2

In addition, the Offerors must include the Excel Spreadsheet with the Breakdowns of the Proposed Estimated Costs

*It should be noted that the IDIQ does not require a business proposal.

**The page limitation is inclusive of all attachments but does not include: Human Subjects section, bio-sketches/resumes/CVs (each individual should not exceed 10 pages), references, a list of Standard Operating procedures (SOPs), Data Information Security Plan, Summary of Related Activities, NIST 800 53 Self-Assessment. Proposal Cover sheet, Section Dividers that do not contain information other than title of Section, Title and Back Page and Table of Contents and Letters of Commitment.