Amendment 1 to RFP Final.pdf

Amendment # 1 to RFP-NIH-NIAID-DAIT-75N93020R00021

Amendment to Solicitation No.:

RFP-NIH-NIAID-DAIT-75N93020R00021

Amendment No. 1

Issue Date: April 7, 2021

Effective Date:

Proposal Due Date:

April 7, 2021

May 24, 2021 3:00 pm (Unchanged)

Issued By: Deborah Blyveis Contracting Officer

NIH/NIAID/DEA

Office of Acquisitions 5601 Fishers Lane Room 3B6* MSC 9821 Rockville, MD 20852

Point of Contact: Deborah Blyveis, Contracting Officer blyveisd@niaid.nih.gov

Name and Address of Offeror: To All Potential Offerors

Offerors MUST acknowledge receipt of the amendment by Amendment number(s) and date of the amendment(s). Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

The deadline for submitting questions is April 26, 2021.

SECTION 1- QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

1. How many awards does NIAID intend to award on this solicitation? It is a single award contract or multi-award contract?

Answer: One award is anticipated.

2. Per Page 86 - How many Past performance factor should the offeror provide?

Answer: For proposal evaluation purposes the Past Performance Factor* “will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.” See page 86 (all pg.

number references in the answers are to numbers at the bottom of the page) of the RFP for details.

*The “Past Performance Factor” is determined by the government and separate from the “Past Performance Information” required to be provided by the contractor on page 57 of the RFP under paragraph 14, “Past Performance Information.”

3. Confirm Past performance factor should be written in the business proposal not the technical proposal as stated on Pages 57 and 83.

Answer: The “Past Performance Information” required on page 57 of the RFP should be “part of [your] Business Proposal.” The information required on pg. 83 should also be included in the Business Proposal.

4. Can you provide a list of the international countries in the Americas where sites are located.

Answer: Current international countries in the Americas include Canada.

5. Page 103-104: Please clarify the LOE for each Option Yr 1 through Option Yr 6. Is it the same

Number of LOE Hours for each year till Option Yr 6 ?For example Option Yr 1: 41,600 hrs, Option Yr 2: ______hrs, Option Yr 3:____ hrs,….

Answer: Please refer to page 12 of the RFP, Article F.3. Level of Effort, paragraph a. which states that the contractor shall provide 41,600 direct labor hours per year for the Base Year and for each Option Year, Options 1-6.

Base: 41,600 hours, Option 1/Yr. 2: 41,600 hours, Option 2/Yr. 3: 41,600 hours, Option 3/Yr. 4: 41,600 hours, Option 4/Yr. 5: 41,600 hours, Option 5/Yr. 6: 41,600 hours, and Option 6/Yr. 7: 41,600 hours.

6. Page 103-104: Please clarify the LOE for Option Yr 7 - 69 ? As above. Also in reference to the statement on Page 118 "The LOE option can be exercised up to nine (9) times per each contract period of performance"

Answer: Please refer to Article F.3., page 12 and Section L., item d. Level of Effort, page 51 of the RFP for details. The LOE of effort can be increased by an increment of 4,160 hours. The 4,160 hour increment can be exercised up to 9 times (Options 7-15) in the Base Year. The LOE increase also applies to the options years (Options 16-69) in the same increments of 4,160 hours, and each increment of 4,160 hours can be exercised up to 9 times per year.

7. Regarding site and site networks needed for monitoring (page 90 of RFP), is ADCT (Autoimmune

Disease Clinical Trials) included in this list as well?

Answer: Regarding Attachment 3, Statement of Work (SOW) spanning pages 1 and 2:

The formatting error that occurred in the initial Request for Proposal (RFP) Number 75N93020R00021 posting (Ref: SOW, version February 23, 2021) is herein corrected below and verified for accuracy and, is consistent with site monitoring summarized throughout the RFP:

Purpose and Objectives 1

The purpose of this acquisition is to:

1. Provide an expanded, wide range of clinical site monitoring services for NIAID-funded clinical research/trials of immune-mediated diseases, including as examples the delivery of monitoring services for:

• the Immune Tolerance Network (ITN)

• Asthma and Allergic Diseases Clinical Research Programs:

o Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) o Atopic Dermatitis Research Network (ADRN) o Consortium for Food Allergy Research (CoFAR) o Inner City Asthma Consortium (ICAC), which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)

• Autoimmunity Centers of Excellence (ACE)

• Transplantation Clinical Research Programs:

o Clinical Trials in Organ Transplantation (CTOT) and in Children (CTOT-C), both of which will be replaced in Fiscal Year (FY) 2021 by the Clinical Trials in Organ Transplantation- Children and Adults (CTOT-CA)

• Non-network clinical research/trials on a limited, as-needed basis, and

• Unanticipated NIAID clinical research studies/trials that may be required in response to public health emergencies and/or emerging needs.

1 Reference: National Institute of Allergy and Infectious Diseases (NIAID) Clinical Site Monitoring Center (CSMC) Contract Opportunity announcement, Notice ID 75N93020R00021, Originally Published Date: February 2, 2021

8. Please confirm the following attachments are exempt from the 150-page Technical Proposal page limit:

a. SOPs List

b. QA/QC Plan

c. Training Plan

d. Project Management Plan

e. Initial Transition Plan

f. Section 508 VPATs

g. 3-page (maximum) CVs for Key Personnel

h. Summary of Related Activities

i. Technical Proposal Cost Summary

Answer: a.-f. and h.-i. from the above list are NOT exempt from the 150 page limitation. CVs, g., are exempt.

9. Attachment 5 (Reporting Requirements and Deliverables), page 5 of 6; please confirm that line item 13 in the Deliverables table, Draft and Final Research Protocol and Statistical Analysis Plan (SAP), is included in error and should be removed.

https://beta.sam.gov/opp/e4a42da5c8e841abaaae1aa8abf4becc/view?index=opp&notice_type=p,o,k,r,s&page=1&organization_id=100019747&naics=&sort=-modifiedDate&keywords=niaid&inactive_filter_values=false&is_active=true&date_filter_index=0 https://beta.sam.gov/opp/e4a42da5c8e841abaaae1aa8abf4becc/view?index=opp&notice_type=p,o,k,r,s&page=1&organization_id=100019747&naics=&sort=-modifiedDate&keywords=niaid&inactive_filter_values=false&is_active=true&date_filter_index=0

Answer: Regarding Attachment 5, Reporting Requirements and Deliverables, item 13: The statistical approach and analysis plan is applicable to research and development (R&D) innovation (Reference:

Advancing the field of risk-based monitoring through innovation).

10. Attachment 7 (Additional Business Proposal Instructions and UCAs), page 3, states offerors should “assume that, on average, 93% of the active site monitoring sites/site monitoring visits are located throughout the United States, 4% in the United Kingdom, and 3% in Australia.” Further down on page 3 of Attachment 7, under the Travel heading, it states offerors should “assume that 93% of the site monitoring visits will occur in the United States and the remainder in Rest of World, primarily in the United Kingdom and Canada.” Please confirm the percentage of visits offerors should assume across the United States, United Kingdom, Canada, Australia, and Rest of World countries.

Answer: Country locations of clinical sites participating in the clinical studies/trials currently: Includes domestic (US) and foreign clinical sites (located in countries such as Canada, Australia, and the United Kingdom). For the purposes of your application, assume that, on average, 93% of the active site monitoring sites/site monitoring visits are located throughout the United States, 3% in the United Kingdom, 2% in Canada and 2% in Australia.

11. Are any type of study-specific contracted audits included as part of the QA/QC plan, such as site audits or file audits in this case?

Answer: The content in the solicitation is correct, as is currently posted.

Amendment # 1 to RFP-NIH-NIAID-DAIT-75N93020R00021