Regulatory Management Center RFP No. 75N93020R00015 - Amendment 1.pdf

Amendment No. 1 Solicitation NIAID DAIT RMC RFP 75N93020R00015

AMENDMENT ONE (1)

OFFICE OF ACQUISITONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Room 3D32, MSC 9821 Rockville, MD 20852

Solicitation Number: RFP 75N93020R00015

Date of Solicitation Issuance: 09/04/2020

Date of Amendment No.1 Issuance: 11/09/2020

Number of Pages: 5

Points of Contact:

Albert Nguyen, Contracting Officer E-mail: nguyenal@nih.gov

Liem Nguyen, Contracting Officer E-mail: liem.nguyen@nih.gov

The hour and date specified for receipt of Offers remains unchanged.

Offerors must acknowledge receipt of the amendment by Amendment number(s) and date of the amendment. Include a statement of acknowledgement in your proposal submission.

Failure of acknowledgement may result in rejection of your offer.

As part of this Amendment, we request that all questions pertaining to the RFP be submitted to the Government no later than 3:00 PM ET November 12, 2020.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

mailto:nguyenal@nih.gov mailto:liem.nguyen@nih.gov

PURPOSE OF SOLICITATION AMENDMENT

The purpose of this amendment is to provide responses to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

SPECIFIC RESEARCH AREA QUESTIONS

The Government’s responses to questions received regarding this solicitation are as follows:

Question 1: Attachment 1, Page 2: 2. Total page count does not include: Title and Back Page; Table of Contents; and Section Dividers that do not contain information other than title of Section. CVs shall not exceed 3 pages.

Will DAIT please consider excluding CVs and Mandatory Qualification Criteria from the 150- page limit?

Answer 1: CVs and Mandatory Qualification Criteria items a. and b., from page 86 of the RFP may be excluded from the 150-page limit.

Question 2: Section M, Pages 85-86, M.3. Mandatory Qualification Criteria: With regard to the requirement to provide “copies of the license for the eCTD and eTMF systems,” is the Government looking for offerors to provide copies of the fully-executed license agreements? Is it acceptable to provide a redacted version that provides NIAID/DAIT with only the essential pieces of information needed to meet the Mandatory Qualification Criteria at the time of receipt of Original Technical Proposals (e.g., fully-executed agreement, license agreement active dates, etc.)?

Answer 2: A redacted License agreement will be sufficient.

Question 3: Will you explain further the responsibilities of the contractor related to the eTMF? It is our understanding that the CRO generally holds and manages the TMF because they are managing the trial(s).

Answer 3: That is correct.

Question 4: Will the contractor be required to manage trials / trial data?

Answer 4: No, the contractor will not be required to manage trials/trial data. Please refer to Attachment 3 – Statement of Work, Section 1.1 for details:

Attachment 3 – SOW, Background and Introduction, paragraph 1.1.

The purpose of this contract is to support regulatory management activities for all clinical research, clinical trials and nonclinical research supported by NIAID.

1.1. Regulatory Management Support Activities: In instances where DAIT serves as the IND or IDE sponsor (Holder), the contractor shall provide the full spectrum of support services described in Section 3 “Technical Requirements” of this SOW. In specific instances, the Contractor may be responsible for carrying out only a subset of these regulatory support functions and the subset of activities will be agreed upon by the COR and the Contractor;

examples of specific instances: (i) the clinical study or trial is exempt from US IND or outside US IND-equivalent requirements; (ii) the NIAID-funded investigator serves as the IND or IDE sponsor (holder), and assumes all country-specific sponsor regulatory and legal obligations including all RHA communications, data management, pharmacovigilance and site monitoring.

Question 5: This RFP says it is a recompete. Will you describe the nature of the recompete?

Is it a routine recompete or is there a need for a new service provider?

Answer 5: The RFP is a recompete for continued services.