CCTN RFP Amendment 2 11-22-2019 Final version.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

11/25/2019

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.: 0002

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: May we include attachments or appendix items to the technical and business proposals such as:

COI investigator documents, institution sIRB policy, proof of GCP trainings for investigators, storage facility checklist and related deliverable items?

Response: Yes, offerors may include in their proposals any information or documents deemed essential for the evaluation and analysis of their proposals. Please see Technical Proposal Instructions on page 97 and Business Proposal Instructions on page 116. Please also refer to Attachment 1, Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website.

2. Question: Can a table of deliverable items be included as an attachment or appendix item in the technical and business proposals?

Response: Yes, Offerors may include in their proposals any information or documents deemed essential for the evaluation and analysis of their proposals.

3. Question: Is there a page limit for the Business Proposal?

Response: No.

4. Question: Could you please provide us with the following: the HHS Information Security Program security requirements outlined in the HHS Information Security and Privacy Policy (IS2P) referenced on page 35 of the RFP?

Response: The HHS Information Security Program requirements will be provided once the contract is awarded. Primarily, the HHS Information Security and Privacy Policy (IS2P) maps to NIST 800-53, Rev.4 and other NIST Special Publications (SP) (e.g. NIST 800-37 and NIST 800-39) among others. Also, please refer to the following link for information concerning HHS Information Security and Privacy Policies:

https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/index.html

5. Question: Attachment 5 - Section K - Representations, Certifications, and Other Statements of Offerors is listed in Section J under Solicitation Attachments; but, is not listed as a necessary attachment under either the Business or Technical Proposal sections. However; page 72 of 175 says to include it in the Business Proposal. Can I assume including it under the Business Proposal would be correct?

Response: Yes, please complete and include Section K – “Representations, Certifications, and Other Statements of Offerors” as part of your Business Proposal.

6. Question: The link for Attachment 20 – Privacy Act System of Records is unavailable.

Response: The following link is to access Attachment 20 - Privacy Act System of Records:

https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/Privacy%20Act%20Systems%20of%20R ecords%20Notices%20(SORNs).pdf#search=privacy%20act%20system%20records

7. Question: The link for Attachment 23 – Cumulative Inclusion Enrollment Report is unavailable.

Response: Below is the correct link to access Attachment 23- Cumulative Inclusion Enrollment Report:

https://grants.nih.gov/grants/funding/phs398/CumulativeInclusionEnrollmentReport.pdf https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/index.html https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/Privacy%20Act%20Systems%20of%20Records%20Notices%20(SORNs).pdf#search=privacy%20act%20system%20records https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/Privacy%20Act%20Systems%20of%20Records%20Notices%20(SORNs).pdf#search=privacy%20act%20system%20records https://grants.nih.gov/grants/funding/phs398/CumulativeInclusionEnrollmentReport.pdf

8. Question: If we delay our application until the next cycle, when next should we expect another release of this announcement (7 years)?

Response: The last two IDIQ contracts were awarded for 7 years. However, there is no assurance that the same will occur in the future as different factors are considered at the time a project is approved for recompetition.

9. Question: What documents should be included under the Technical Proposal and what documents should be included under the Business Proposal and in what order? Would it be possible to provide us with a comprehensive checklist?

Response: There is no checklist available to provide as the Offerors should include in their proposals documentation that they determined necessary to demonstrate their capability and capacity for the evaluation of their proposals. Please see SECTION L - Instructions to Offerors subsection that begins on page 81 of the RFP. This section establishes the acceptable minimum requirements for the contents of the proposals. Particularly, please refer to 2.b. Technical Proposal Instructions (page 97) and 2. c. Business Proposal Instructions (page 116) of the RFP. As stated on page 128, for the Technical Proposal, “The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the SOLICITATION. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the SOLICITATION.” Offerors must include sufficient information to evaluate their proposals based on the Technical Evaluation Factors included in Attachments 6 and 6A (pages 170-173).

10. Question: Page 113 of the RFP states that offerors must submit the PHS Human Subjects and Clinical Trials Information Form; however, the list of attachments lists it as informational only (Attachment 22).

Response: Attachment 22 - PHS Human Subjects and Clinical Trials Information Form is provided for informational purposes only as Sample Task Order 2 will not be awarded at this time. Therefore, the Offerors are not required to submit the form as part of the proposals.

11. Question: On Page 5 of the directions for the PHS Human Subjects and Clinical Trials Information Form, this form states that adding a new delayed onset study is inapplicable to contract proposals. The only other option seems to be to add a new study as an attachment. Would it be appropriate to use Sample Task Order 2 as the attachment to this form, if it is indeed required?

Response: The PHS Human Subjects and Clinical Trials Information form is not required as part of the proposal since the study under Sample Task Order 2 will not be initiated at this time.

12. Question: Should the Phase IIB clinical trial incorporate any dose finding for the IM progestin?

13. Question: The statement below from Sample Task Order 2 suggests that study design should be a PK

Phase II and the progestin of interest is LNG. Are those assumptions accurate?

“The active progestin has a long history of clinical use in a variety of contraceptives (pills, intrauterine devices, and implants) and its efficacy and safety are well recognized. A phase I trial of this compound has demonstrated pharmacokinetic/pharmacodynamic evidence of ovulation suppression for 4-months in normal weight and obese women. This trial will evaluate contraceptive effectiveness.”

Response: Sample Task Order 2 is a Phase 2B study to evaluate contraceptive effectiveness. Offerors should only assume the product is an IM progestin injection.

14. Question: Page 133 states: “The active progestin has a long history of clinical use in a variety of contraceptives (pills, intrauterine devices, and implants) and its efficacy and safety are well recognized. A https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files phase I trial of this compound has demonstrated pharmacokinetic/pharmacodynamic evidence of ovulation suppression for 4-months in normal weight and obese women. This trial will evaluate contraceptive effectiveness.” A new progestin injectable product should demonstrate unique advantages in comparison to our existing DMPA product. Would a comparator efficacy clinical trial be of value (and something we could propose) comparing LNG 4 month injectable to depo-medroxy progesterone acetate q 3-month injection? Alternately, should we focus more on a dose finding design where we are assessing different doses of the progestin injectable?

Response: The study is intended to be a Phase 2B study to evaluate contraceptive effectiveness of the investigational product. Please see Attachment 3B - Sample Task Order 2 SOW. In addition, Offerors should only assume the product is an IM progestin injection.

15. Question: Issues related to access and administration are aspects of utilization that are important to consider.

Response: The Offeror should assume that the issues related to access and administration have been addressed in earlier studies.

16. Question: Has the network already developed investigations of SQ vs IM vs pharmacist vs self-administration? My understanding is that we should focus on IM LNG (and not other routes of administration).

Response: The Offerors should only assume the product is an IM progestin injection.

17. Question: Can we randomize women to DMPA vs study drug?

Response: This is not part of the sample study design.

18. Question: Should Sample Task Order 2 include a trial design?

Response: Yes, the trial design is a Phase 2B contraceptive effectiveness study.

19. Question: Should Sample Task Order 2 include a statistical analysis plan?