Amendment__3.pdf

Amendment #3 to NIAID-DAIT-NIHAI201800018 CIVICs Statistical, Data Management and Coordination Center (SDMCC)

Amendment to Solicitation No.:

NIAID-DAIT-NIHAI201800018

Amendment No.: 3

Issue Date: October 25, 2018

Effective Date:

Proposal Due Date:

October 25, 2018

November 29, 2018 3:00 pm (Unchanged)

Issued By: Tom Bahrami, MBA Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane Room 3C20 MSC 9821 Rockville, MD 20852

Point of Contact: Maribel Miranda, Contracting Officer Maribel.Miranda@nih.gov

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals remains unchanged. Offerors must acknowledge receipt of this amendment. Failure to receive your acknowledgement of this amendment may result in the rejection of your offer.

All questions pertaining to the RFP shall be submitted to the Government no later than November 19, 2018, 3:00pm

EST (CHANGED).

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.

Question 1: SOW Technical Requirements – Item 2.a.iv. (pg. 4 of 10); please provide more information on “toxicology metadata”.

Response to question 1:The SDMCC is supporting data management and analysis for all CIVICs components described in Research Area 003 of the NIAID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH- NIAID-BAA201 – Amendment 1 (https://www.fbo.gov/index.php?s=opportunity&mode=form&id=5e1010eba49a2a1b0b77176f013dbd61&tab=core& _cview=1) o Component A: Vaccine Center o Component B: Vaccine Manufacturing and Toxicology Core o Component C: Clinical Core

Component B Toxicology language from the BAA:

Perform IND-enabling pre-clinical safety and toxicity studies for vaccine products including:

• Systemic toxicity. Include dose-ranging studies of systemic and organ specific toxicity, and acute and repeat toxicity.

• Local site reactivity studies. Include detailed clinical observations and histological evaluation of tissue at the injection or application site, or other visible lesions from biopsies or term necropsy samples.

• Biodistribution/Integration. In the case of specific products such as DNA and some vector-borne vaccines, perform studies to determine the biodistribution of the product. If the product persists above threshold levels in a tissue, perform an integration analysis.

• Genetic toxicity. In the case of specific products such as DNA and vector-borne vaccines, a pivotal GLP pre-clinical study shall focus on assessment for the potential of the nucleic acid vaccine to recombine with endogenous host DNA sequences and integrate into host chromosomes. Studies designed to address the potential for integration shall use the most sensitive methods available.

• Tumorigenicity studies. Tumorigenicity studies may be required under certain conditions; for example, if the pre-clinical genetic testing demonstrates evidence of integration activity and/or broad tissue distribution.

• Reproduction toxicity studies. Reproduction toxicity studies shall be performed prior to the use of products in pregnant women. Such studies shall include, for example, fertility, general reproductive performance, teratogenicity and developmental toxicity.

• Other studies. Includes other toxicity/safety studies and evaluation of vaccine components, adjuvants, alternate formulations, and delivery systems (e.g., induction of autoimmunity).

Question 2: SOW Technical Requirements – Item 2.c.vi.i. (pg. 5) references “an online tracking system for the receipt, reporting, and disposition of SAEs.” Please clarify if a full safety management system to include MO safety report review is required, or if the DAIT CRIS safety module will be used for this purpose.

Response to question 2: The SDMCC will be the safety desk of record for the clinical trials conducted by the CIVICs Clinical Core, including Medical Officer safety report reviews (which may be conducted by NIAID-appointed Medical Officers and/or CIVICs Clinical Core Medical Officers). The SDMCC will need to be interoperable with the NIAID Clinical Research Management System (CRMS) so that safety reports can be transferred to CRMS upon NIAID request. This interoperability minimally requires that the SDMCC develop/maintain:

o An operational Safety Desk o A database of record for tracking safety data o MedDRA coding of events capability/expertise o A safety database/system capable of generating XML data according to a pre-defined schema/specification that would be provided post award.

NOTE: In responding to this question, NIAID noticed a typographical error in Item 2.c.vi.vi of the SDMCC SOW – “NIAID Clinical Research Information System (CRIS)” should be “NIAID Clinical Research Management System

(CRMS)’”.

Question 3: SOW Technical Requirements – Item 3 (pg. 6) - “CIVICs Program Data Access and Resource Sharing”: please clarify, is the Government expecting the portal to also provide a “Workbench” for data processing on the cloud, or a portal for data storage and sharing only?

Response to question 3: Item 3 describes the requirements for a single portal capable of:

A) provide data/information sharing within the CIVICs program (i.e., with all CIVICs contractors); and B) providing public access to CIVICs-related information, but not data.

Item 2.a. of the SOW (Data Management and Analysis) requires the SDMCC “to implement tools/processes to facilitate collection, harmonization, tracking, updating, query, and visualization and analysis of metadata, experimental data and information generated across the CIVICs investigators”.