Amendment 1-RFP NIH-NICHD-CDP-2020-2.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

03/13/2020

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, MSC 7000

BETHESDA, MD 20892-7000

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-2020-2

X

9B. DATED (SEE ITEM 11)

1/28/2020

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 not 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 extend the date for questions regarding RFP NIH-NICHD-CDP-2020-2 entitled “Contraceptive Clinical Trials Network (CCTN) Male Sites”, provide clarifications based on inquiries received, provide the omitted Technical Evaluation Criteria, and amend Attachment 1 of the RFP.

DUE DATE: April 28, 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

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-2020-2

AMENDMENT NO.: 01

CONTINUATION PAGE

RFP No. NIH-NICHD-CDP-2020-2 is amended as follows:

1. Solicitation Section A – Solicitation/Contract Form, Item 13 is modified to state “Questions must be submitted in writing via email by March 24, 2020.”

2. RFP Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, paragraph 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.

3. Section M, EVALUATION FACTORS FOR AWARD, Item 6. TECHNICAL EVALUATION FACTORS is modified to add the following two sets of technical evaluation criteria entitled “CCTN IDIQ Contract and Task Order No. 1 Male Sites” and “Sample Task Order No.

2 Male Sites”.

Technical Evaluation Criteria

CCTN IDIQ Contract and Task Order No. 1 Male Sites

1. Personnel 35 Points

The qualifications of the principal investigator, co-investigator, and other personnel will be evaluated for their ability to organize and manage contraceptive clinical trials as well as the demonstrated ability to accrue subjects for previous trials relevant to contraceptive evaluation. Applicants should provide a thorough description of the experience and qualifications of personnel who will be assigned to this program. Proposals should show the composition of the work group and document the general qualifications of the group and describe recent experience of the group with clinical trials of contraceptives. Some clinical trials for male contraception require expertise in evaluation of semen analysis, reproductive hormone evaluation, etc., requiring an appropriate level of skill in key personnel and support personnel anticipated to participate at the clinical site. The curriculum vitae of each of the proposed personnel and consultants, including education, employment history, recent experience with contraceptive clinical trials, and other accomplishments and relevant publications must be included. If proposed personnel are not currently members of the staff, a letter of commitment or other evidence of availability is required. If the proposed individual has not been identified, a summary of qualifications and the approach to recruitment must be described. A schedule indicating how soon after the contract award each of the proposed personnel would be available should be included. If applicable, the offeror’s proposal on the approach to acquiring new staff will be evaluated.

a. Principal Investigator (20 Points)

The proposed principal investigator must be a board-certified physician with expertise in contraceptive product evaluation. Extensive experience with contraceptive clinical trials is essential. The principal investigator will be encouraged to propose ideas for new studies and to develop new protocols in cooperation with representatives of the clinical coordinating center and the NICHD Program Staff. The principal investigator will be expected to provide informal consultation on issues related to contraception and other areas of reproductive health relevant to the development of clinical trials to the NICHD Program Staff. The ability to provide these services will be evaluated, as will the ability to respond in a timely manner as task orders are issued and experience in exercising fiscal responsibility for an activity of similar scope and complexity.

b. Co-Investigator, Study Coordinator, Data/Research Manager and Other Personnel (15 Points)

i. Co-Investigator (5 Points) Sites doing contraceptive clinical research much have a co-investigator. The co-investigator must have the appropriate credentials, training and experience with clinical trials in order to serve in a supportive role in the conduct of the trials as well as back-up in the case of emergencies or unavailability of the principal investigator.

ii. Study Coordinator and Data/Research Manager and Other Personnel (10 Points) Other mandatory personnel include a study coordinator and a data/research manager. These individuals must have experience in conducting contraceptive clinical trials. If these individuals have not yet been identified, the site must provide evidence that it is able to hire and train qualified individuals to perform the responsibilities of these roles adequately.

a) If subcontractors or consultants are proposed, their qualifications and anticipated contribution to the primary clinical trial site must be described.

b) The availability of site personnel to participate in the activities outlined in the

Statement of Work for the Task Order for Core Administrative Task will be evaluated.

2. Organizational Experience and Facilities 30 Points

a. Organizational Experience (20 Points) Experience of the offeror and proposed subcontractors with respect to similar projects, including project dates and sponsors, specific responsibilities respect to these projects, the type of personnel allocated to these projects and their respective level of effort, accomplishments with respect to these projects, and evidence of meeting performance objectives and submitting deliverables on schedule. Specific demonstrations of the ability to recruit, enroll, and retain subjects in compliance with project protocols and timeline objectives will be evaluated, including access to special populations and pools of established research eligible subjects. The ability to identify and recruit a target population of reproductive age women who are eligible for the study will be evaluated. In the case of a Phase I study, plans for recruitment and documentation of the ability to recruit at least 50 subjects per year must be described. For a Phase II/III study, documentation of the ability to recruit and plans for the recruitment of 100 subjects per year must be described. Offeror should describe the particular strengths and types of trials their organization is equipped and staffed to complete.

b. Facilities (10 Points)

Availability and adequacy of clinical facilities, including clinical services to meet subject needs during non-standard business hours, diagnostic laboratory facilities and equipment for electronic communication, provisions for blood sampling and storage, and drug or device storage will be evaluated.

3. Understanding of the Sample Task Order No. 2 Technical Approach 20 Points*

*This score equals 20% of the total score earned on Sample Task 2.

4. Management Plan 15 Points

The offeror’s management plan will be evaluated for the ability to carry out both the Task No.1 and Sample Task Order No. 2. In the case of the both the Core Function Task and the Clinical Trial Task Order, the offeror’s detailed management plan organizing the work, including staff hours or days planned per task and scheduling of deliverables will be evaluated for reasonableness and timeliness.

In each case, a summary describing responsibilities, accountability and timelines for activities must be described.

An organizational chart delineating lines of authority and backup for key personnel must be provided.

Design and implementation of procedures to ensure proper collection of data, protection of participant confidentiality, and data security will be evaluated. Demonstrated ability to respond in a timely manner to Requests for Task Order Proposals, demonstrated ability to initiate work promptly after issuance of Task Orders, and experience in exercising fiscal responsibility for an activity of similar scope and complexity will be evaluated.

TOTAL POINTS: 100 Points

Technical Evaluation Criteria Sample Task Order No. 2

Male Sites

“Safety and tolerability, pharmacokinetics, and pharmacodynamics of a long acting injectable progesterone analog with topical testosterone in healthy male volunteers”

For this Sample Task Order the offeror should show understanding of 1) Good Clinical Practice and Food and Drug Administration (FDA) guidelines for the conduct of clinical trials; 2) the overall clinical trials process and 3) protection of patient confidentiality and data security. In addition, their accessibility to special populations, including a range of ethnic/minority groups and demonstration of an understanding of the current DHHS regulations for reporting gender/race/ethnicity will be evaluated.

1. SUCCESSFUL EXPERIENCE WITH SIMILAR STUDIES 30 Points

Demonstrate and provide documentation of successful recruitment and retention of subjects within the time frame projected for the enrollment period in studies of a similar nature. Demonstrate ability to recruit rapidly once enrollment period begins. Demonstrate ability to consistently generate high quality data. Please state each cited study’s name and period of performance. Please list contraceptive studies separately from non-contraceptive clinical trial experience.

2. EXPERTISE

30 Points

Demonstrate expertise of the investigator and key support staff in the performance of the type of clinical studies and techniques described in this request for proposal. Some clinical trials require ability to perform semen analysis and evaluate reproductive hormone levels, requiring an appropriate level of skill in key personnel and support personnel anticipated to participate at the clinical site.

3. RECRUITMENT PLAN

30 Points

Adequacy of the Offeror’s proposed Recruitment Plan for the trial based on a demonstrated appropriate, available, and accessible study population of reproductive age men who are eligible for the clinical trial, including: (a) number of subjects anticipated to be recruited, (b) brief proposal of plan for recruiting containing the items described above, (c) an appropriate level of detail regarding key personnel and support personnel anticipated to participate at the clinical site. (d) availability and adequacy of clinical facilities, including clinical services to meet subject needs during non-standard business hours.

4. TECHNICAL PROPOSAL CLARITY

10 Points

Adequacy and clarity of the Offeror’s technical proposal for the trial. Specifically, a clear description and adequacy of the approach and demonstration of the ability to carry out the requirements of task order SOW, including enrollment strategy plan, diversity of proposed population if the protocol requires that population, plans to optimize compliance and retention rates.

TOTAL: 100 Points*

* Twenty percent (20%) of the total points will comprise the points for the IDIQ contract and Task Order No. 1’s technical criterion number 3: “Understanding of the Task Order No. 2 Technical Approach.” For example, a score of 90 points on Sample Task Order 2 equates to 18 points for Task Order No. 1’s technical criterion number 3 (90 x .20 = 18).

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. Attachment 1, page 2 of 3 Indicates that proposal must have margins of one inch on all sides. This is different for all the NIH request for proposals and grant application. Please kindly confirm that the margin requirement is correct.

Answer 1: The margin requirement specified in Attachment 1 of the RFP is correct.

2. Attachment 1 page 2 of 3, please kindly confirm that the excel spreadsheets of the business proposals are not included in the page limitations but as a separate file.

Answer 2: The excel spreadsheets of the business proposals are not included in the page limitations.

Please note that the business proposal does not have page limitation.

3. Subcontractors – As there are page limitations of 25 pages of the IDIQ application, do we need to provide the detailed information for each of the subcontractors as for the primary site because the page limitation will not allow detailed description? Can we just summarize these centers in a paragraph unless they will be actively involved in the proposed Sample Task order 2?

Answer 3: If subcontractors or consultants are proposed, a description of the qualifications, experience and anticipated contribution to the primary clinical trial site must be provided. See Attachments 21 and 21a - Technical Evaluation Factors (included in this Amendment as part of Section M EVALUATION FACTORS FOR AWARD) for additional information.

4. As subcontracts have to be managed by the primary site. The PI of the main contract site needs assistance in managing all the projects and the subcontracts. Does Task Order 1 allow a proposal of a part-time project manager?

Answer 4: If a subcontractor is proposed for a specific study, any proposed effort/cost related should be included for consideration in the study task order’s proposal.

5. For Task Order 2 we will assume that we will recruit 30 subjects at our site/subsites for this study. As we need to propose dose finding studies for this combination, the 30 subjects may not be adequate for our application. Can we assume that there will be other sites doing the same study like current collaborative sites University of Washington and us. So in the protocol we will propose 30 subjects at our site/subsites and more research participants at other sites so we can write a proposal with adequate statistical power for safety and tolerability and preliminary efficacy.

Answer 5: For budget purposes, offerors should assume recruitment of 30 subjects within a period of 12 months assuming there will be other sites participating in the same study. In addition, offerors should provide the number of subjects per month that the offeror projects to enroll.

6. Please confirm that for Sample Task Order 2, the planned enrollment table is not included in the page limitations.

Answer 6: The planned enrollment table is not included in the page limitations for Sample Task Order 2.

7. Please confirm that appendices are not allowed (because in our prior application we inserted the detailed protocol in the appendix). Only the items referred on page 3 of 3 of Attachment 1 are allowed?

Answer 7: Additional documents such as appendices may be included as long as the total page limit is not exceeded.

8. For Task Order 2 we need to include protection of human subjects and DSMB section. These requirements are in the RFP pages 101 to 112. Please clarify whether the human subjects and DSMB sections are excluded from the description of the project in Sample Task Order 2.

Answer 8: The human subjects and DSMB sections are excluded from the page limitation – please see revised page limitation information in Attachment 1, paragraph B on this modification.

9. Are international sites (outside the USA) allowed to participate in this solicitation response to RFP.

Answer 9: International sites are allowed to submit a proposal in respond to this solicitation provided they are registered in the System for Award Management (SAM) (http://www.sam.gov) at the time of proposal submission as is required of all offerors.

10. On Page 100, indicating HUMAN SUBJECTS as a separate file. Is this correct and is there a page limit on the Human Subjects document.

Answer 10: The “Human Subjects” information shall be included as a separate section in the IDIQ technical proposal and does not have a page limit.

11. Page 105, Section titled “Information Required for ALL Clinical Research Proposals” is this section required to be addressed in the proposal now or (after award) at time when task order request for proposal.

Answer 11: This section is required to be addressed in the initial proposal submission due on April 28, 2020. Please see Note 2 on page 105 for guidance on how to address this section.

12. Page 106, Section titled “NIH defined Phase III clinical trials NIH defined Phase III clinical trials” require that: a) all proposals and/or protocols provide a description of plans to conduct analyses, as appropriate, to detect significant differences in intervention effect” is this section required to be addressed in the proposal now or (after award) at time when task order request for proposal?

Answer 12: For this solicitation it is not required that the proposal includes a plan to conduct analyses.

The offeror is not required to address this section now. This will be developed by the coordinating center in collaboration with the investigators.

13. Page 113, Section titled “HIV Antiretroviral Treatment Trials” as these studies do not involve HIV/AIDS research, this section is not applicable i.e. no plan is required in the proposal, correct?

Answer 13: Correct, the Section titled “HIV Antiretroviral Treatment Trials” is not applicable to this requirement. Therefore, no plan is required.

http://www.sam.gov/

14. Page 117, Section on BUSINESS PROPOSAL INSTRUCTIONS, please clarify whether certified Cost or Pricing Data is required, do they only provide response based on #3 (page 118) and disregard #4 (Page 119)?

Answer 14: Certified cost or pricing data is not required for this solicitation. However, the offerors must submit data other than certified cost or pricing data. Please disregard #4 Page 119.

15. Page 131, other sections of this RFP states Past Performance for contracts in the last 5 years. Please clarify Past performance requirement.

Answer 15: On Page 131 “Pertinent contracts” item 12d requires information to use to evaluate the qualifications of the offeror. Page 85 Item 14, Past Performance Information applies as stated.

16. Page 132, Section on “Proposer's Annual Financial Report” as a small business what in real terms are the minimum financial capital that must exist to win this contract as a prime contractor?

Answer 16:As stated in FAR 9.103 (b): “…If the prospective contractor is a small business concern, the contracting officer shall comply with FAR subpart 19.6, Certificates of Competency and Determinations of Responsibility.”

17. Page 132, as a privately owned-small business is a contractor’s annual financial report absolutely required to qualify to response to this solicitation i.e. is absence of submitting a financial report disqualifying?

Answer 17: Please see answer to question number 16.

18. Page 136 -137, Section titled “TECHNICAL EVALUATION FACTORS” states it contains “two” sets...but the RFP contains 3 sections for response (IDIQ, Task Order 1 and Sample Task Order 2). Please clarify the evaluation factors.

Answer 18: The IDIQ and Task Order 1 will be evaluated under one set of Technical Evaluation Criteria and Sample Task Order 2 will be evaluated under a separate set of Technical Evaluation Criteria.

19. Page 137 states attachment 6 and 6a, but there are no attachments named 6/6a in Section J. Please clarify.

Answer 19: The attachments were inadvertently omitted from the RFP and are described in this amendment. See item number 3 pages 2-6 of this Amendment.

20. Attachment 1, Page 2, how and where should the Humans Subjects Separate document/file be submitted.

Answer 20: The “Human Subjects” section shall be included in the IDIQ technical proposal.

21. Attachment 1, Page 2, instructions state the Business Proposal with two sections (Task Order 1 and Sample Task Order 2), what is the total number of required Past Performance to be outline in the Business Proposal, 4 total or 4 for each Section (total 8)?

Answer 21: Four total.

https://www.acquisition.gov/content/part-19-small-business-programs#i1100603