QA_PHASE I_NIAID eCTD_RFQ2076690.pdf

Questions and Answers Electronic Common Technical Documents (eCTD) Publishing and Reviewing

Software Solicitation ID: RFQ-2076690

7/30/2021

I. PHASE 1 QUESTIONS

Q1: What is the annual submission volume (either known or estimated)?

A1: For the period 7/1/2020 – 7/1/2021: New applications = 17; New sequences/assemblies = 660.

Previous years were similar.

Q2: The SOW only states that FedRAMP certification is “highly desirable”, but does the solution need to be hosted in a FedRAMP-certified environment? Are there specific FedRAMP compliance items that are being considered as part of the decision making activities for this project?

A2: A FedRAMP-certified environment is not required. The Institute has had success implementing hosted solutions on FedRAMP-certified IAAS. The government will require a high confidence that quoter's solutions can obtain FISMA-moderate compliance.

Q3: NIAID is currently using a third-party Document Management System which will be replaced with the new solution.

a. What are the requirements for migrating source submission content to the new system?

A3a: Migrate all sequences and applications from legacy eCTD system. All legacy sequences and applications will have applicable XML backbone. Provide a Migration Plan (pre-migration) and Migration Summary Report (post-migration).

b. If content needs to be migrated, will relationships between source and published content need to be maintained (i.e. ability to check for new versions of current documents for a new submission in the new application)?

A3b: Desirable but not required.

c. What is the profile of data to be migrated (i.e. number of source files, including renditions;

total size)?

A3c:

• Total Applications to be migrated = 164

• Total Submission Sequences to be migrated = 2380

• Total number of Source Files (including renditions) = 26,713

• Total Size of data to be migrated = 120GB

d. What method is required to/approved for data transfer from NIAID to the Cloud (agency data transfer tool; third-party system; etc.)?

A3d: No specific method is required but any solution must use sufficient encryption and data protection in transit and at rest.

e. Can you provide additional information about the current types of workflows that will be needed in the new system?

A3e: NIAID declines to respond.

Q4: The department will be migrating legacy application sequences (approximately 120GB in size) to the new Cloud solution.

a. How many applications will be migrated?

A4a: Total Applications to be migrated = 164

b. How many submission sequences?

A4b: Total Submission Sequences to be migrated = 2380

c. SOW states that the electronic submissions are in the eCTD format. Are there any legacy IND sequences not in eCTD form, that may need to be migrated with their respective applications?

A4c: No.

Q5: Besides standard CTD-based metadata, what specific attributes need to be configured in the new system?

A5: NIAID declines to respond.

Q6: The SOW states that the system needs to support configurable naming conventions. Does this mean naming values for standard submission attributes and published file names, or are there other requirements?

A6: NIAID declines to respond.

Q7: What are the current and future training requirements (i.e. number of sessions and participants for first year, as well as each option year)?

A7: There are several sections of the SOW that address the expectations for training. Training is addressed in sections 5.1.3 Project Team Training, 5.2.2 Training & Documentation, 5.2.6 Updates and 7 Deliverables/Delivery Schedule of the Statement of Work.

Q8: Describe the requirements for submission of published sequences to the regulatory agencies (i.e.

will NIAID users download published data and submit directly from their network, or does the solution need to support the transmission of regulatory submissions from the Cloud)?

A8: NIAID is open to either method.

Q9: Please confirm if eDMS is part of the proposal and should be included in our response and pricing.

A9: Yes, quoters should include an eDMS solution as part of their quote.

Q10: [Implementation] Will users be accessing the system only from within USA? If not please list the countries.

A10. Yes, only from the USA.

Q11: [Implementation] Please advise the preference for disaster recovery and/or failover?

A11: NIAID has no preference.

Q12: [Implementation] What additional NIAID meta-data requirements are needed and do you expect to have this feature available without customizations? Can you provide an example of a naming convention?

A12: NIAID declines to respond.

Q13: [Implementation] Is there any preference on use of database server… Oracle vs SQL?

A13: NIAID has no preference.

Q14: [Implementation] How many environments are expected from this solution?

A14: NIAID has no expectation and is looking for quoter’s recommendation and best practices.

Q15: [Migration] Please detail approximate number of submissions (applications and sequences) for migration under these two buckets:

• Number already submitted and accepted by regulatory agencies

• Number of active submissions (in progress)

A15:

• Total Applications to be migrated = 164

• Total Submission Sequences to be migrated = 2380

• Total number of Source Files (including renditions) = 26,713

• Total Size of data to be migrated = 120GB

Q16: [Migration] Typically for DMS migrations, all active workflows need to be terminated prior to start of migration activities. Please confirm if this is possible.

A16: NIAID declines to respond.

Q17: [Migration] Do you require the migration of any other OpenText objects in addition to the document content and metadata (i.e. audit trails, security groups, renditions, etc.)?

A17: To be determined at project kickoff.

Q18: [Migration] Are documents within the current eCTD submissions dynamically linked to source content within OpenText?

A18: Yes.

Q19: [Other] We assume that only US region DTD is in scope. Please confirm.

A19: Correct – as stated in the SOW.

Q20: [Other] We understood that OpenText server could be retained for effort/cost saving. Should we give one price option with assumption that this server may be retained?

A20: NIAID has no requirement to retain OpenText.

Q21: As XXXX is already active in the SAM system, what information do you need from us in the Phase I response?

A21: NIAID requests representations for both Section 889 provisions be included with the quote as stated on page 43 of the RFQ. The Section J attachment “Full Text Provisions and Clauses” which includes both provisions has been provided. Also reference Section e.5. on page 47.

Q22: ROLE: On the Sam.Gov website for this solicitation, at the bottom it states: Please request a role.

What is that for? Is a role required to respond to this solicitation? Do I need to request a role?

A22: NIAID does not require a role to respond to this solicitation. For questions related to the SAM.gov website please contact the Federal Service Desk (FSD) https://www.fsd.gov/.

Q23: [Volume 1 Requirement] Please provide greater clarity and details of what you are looking for specifically with regards to “track record” (Describe your proposed product’s track record with eCTD submissions.)

A23: NIAID is looking for evidence that the quoter’s software has successfully supported regulatory submissions to the FDA or similar agencies.

Q24: [Volume 1 Requirement] Please provide greater clarity and details of what you are looking for specifically with regards to:

a. Describe your experience in regulatory submission operations and familiarity with computer systems validation, 21 CFR Part II and GAMPV

b. Is NIH looking for a YES or NO confirmation of 21 CFR Part II and GAMPV compliance? Or more in depth information? If more in depth, please clarify.

A24: NIAID declines to answer.

https://www.fsd.gov/

Q25: Document: Attachment 2_HHS Subcontracting Plan Template_RFQ2076690 – when does that need to be completed? AFTER Award?

A25: For other than small businesses, a subcontracting plan shall be submitted with the Phase II quote. If applicable, NIAID will finalize an agreed upon plan with the apparent successful quoter prior to award.

Q26: For the 55 eCTD Publisher licenses – do you want these as NAMED or CONCURRENT licenses?

A26: NIAID has no expectation and is looking for quoter’s recommendation and best practices for licensing that will be most advantageous to the Government.

Q27: For the 50 eCTD Reviewer user licenses - do you want these as NAMED or CONCURRENT licenses?

A27: NIAID has no expectation and is looking for quoter’s recommendation and best practices for licensing that will be most advantageous to the Government.

Q28: For the Review licenses: Please confirm this is a VIEW only license with no edit capabilities such as adding annotation notes?

A28: NIAID has no expectation and is looking for quoter’s recommendation and best practices for licensing that will be most advantageous to the Government.

Q29: Please provide a list of which regions the NIH plans to submit to, i.e. US? Canada? Europe?

Other?

A29: US.

Q30: Do you have a need to publish in formats OTHER than eCTD? For example, PAPER or NeeS?

A30: No.

Q31: How many sequences (what is the total estimated #) are there in your current DMS system to be migrated over?

A31: 2380.

Q32: Travel: Will we need to perform all of the activities on site? Or will virtual activities be acceptable?

A32: No activities will be required to be performed on-site.

Q33: Travel: If travel will be required, please provide information around expenses that will need to be accounted for.

A33: NIAID declines to answer.

Q34: Volume: Please provide an estimated number of documents, Versions, and Renditions in your current DMS system.

A34: 26,713.

Q35: Properties: Please provide the document property definitions of your current DMS system. (i.e.

string, number, date/time)

A35: NIAID declines to answer.

Q36: Permission: Please provide the document permission definition of your current DMS system. (i.e.

View, Edit, Administer)

A36: NIAID declines to answer.

Q37: Workflow: Please provide the workflow definition of your current DMS.

A37: NIAID declines to answer.

Q38: Export: Usually the DMS content files ('renditions') can be exported with their meta data (properties and permissions) - usually as XML file(s). For preparation of the migration project, would you please provide the export of all content files with their meta data from your current DMS?

A38: NIAID declines to answer.

Q39: Adapted Properties, Permission and Workflow: Do you consider it appropriate to use the target DMS definition for properties, permissions and workflow when continuing the document processing after the migration?

A39: NIAID declines to answer.

Q40: Migration: Would NIH consider a phased approach where the DMS migration is executed in phases by defined categories (i.e. Business groups, content typed, etc.) while the submission management is already in production?

A40: NIAID is open to different approaches and is looking for quoter’s recommendation and best practices that are most advantageous to the Government.

Q41: SOW Section 1 - For the requirement of the eCTD system to scale up to support multiple divisions: At what level will the access to documents and information need to be restricted?

A41: At the Division level.

Q42: For FISMA certification (SOW 4.1.2-13): the cloud we use is FISMA compliant. Will that be sufficient?

A42: The entire stack (infrastructure, platform, software) must be FISMA or FedRAMP compliant.

Q43: For SOW Section 5, 5.1.8 – please clarify further what the NIH requires? Will the vendor be required to provide information to feed in to that C&A and ATO? Do we need to actually implement additional requirements?

A43: NIAID expects vendors to participate in the development of all IT Security activities including the Certification and Accreditation (C&A) and Authority to Operate (ATO).

Q44: Would NIAID require any additional licenses apart from the “55 eCTD Publisher and up to 50 eCTD Reviewer user accounts” mentioned, for external partners and other collaborators?

A44: NIAID may require additional licenses in the future and is looking for quoter’s recommendations and best practices around licensing.

Q45: How many licenses are needed for the electronic Document Management System (eDMS). Please mention the number of licenses required for the eDMS tool.

A45: NIAID anticipates that eCTD publishers will have access to the eDMS.

Q46: Per Page 5 of SOW, regarding “integration with NIAID specified Security Assertion Markup Language (SAML)-based identity providers” Does NIAID have any preferred single-sign-on (SSO) service provider?

A46: Yes, NIH’s SSO solution which is based on CA Siteminder.

Q47: What is the type and extent of modifications that would be required on eCTD and eDMS workflows?

A47: NIAID declines to answer.

Q48: Does NIAID require automatic archival of published/compiled eCTD sequences to the eDMS system?

A48: NIAID declines to answer.

Q49: What are the drawbacks/major issues faced with the current eCTD and eDMS system being used by NIAID?

A49: NIAID declines to answer.

Q50: Can NIAID specify details about enhancement requests mentioned in routine end user issues technical requirement?

A50: NIAID declines to answer.

Q51: Can NIAID specify more details about group user permissions mentioned in eCTD requirements?

A51: NIAID declines to answer.

Q52: Page 30-36 of RFQ outlines other system requirements and deliverables (SA&A Packages Deliverables – SAP/SAR, SSP, POA&M) are these deliverable expected to be performed by offeror under this solicitation ?

A52: Yes.

Q53: When is the first Section 508 Report due, if appliable to this solicitation?

A53: Quoters shall submit a completed HHS Section 508 Product Assessment Template with their Phase II submission in accordance with solicitation Article H.7. Electronic and Information Technology Accessibility Notice HHSAR 352.239-73. Section 508 Reports are required annually thereafter and schedule will be determined with the contractor after award.

Q54: Page 9 of SOW mentions “logical Partitions for Division” NIAID has both extramural 3 and Intramural research divisions 3. Should the offeror anticipate 6 partitions or 3 partitions? Please specify the number of partitions.

A54: 6.

Q55: Some of the meetings in the SOW (Page 9 and 11) states “on-site”. Is NIAID open to virtual meeting due to on-going Covid-19 pandemic?

A55: Yes.

Q56: Per Page 11 of SOW, when is the FISMA requirement due?

A56: To be determined at project kickoff.

Q57: Per Page 13 of SOW, states 24/5 helpdesk. Will NIAID consider helpdesk hours that reflect normal business hours instead of a 24hrs helpdesk?

A57: Yes.

Q58: On Page 43 of the RFQ document the instructions for quoters has the following, “Go to the System for Award Management (SAM) and complete the Representations and Certifications. The SAM website may be accessed at: http://www.sam.gov ; and…” The question is If we are already certified in the SAM system then this first instruction is really meant for someone that hasn't already gone through the certification process up to this point correct?

A58: Contractors shall be registered in SAM.gov and have completed the Representations and Certifications in SAM.gov.

http://www.sam.gov/

Q59: FAR Clause 52.204-19 Incorporation by Reference of Representations and Certifications (December 2014). The Contractor's representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract. I'm assuming that we don't have to do anything for this particular clause since this basically says that all of our reference of representation and Certifications are already included by reference. Is that the correct interpretation?

A59: Yes, the Contractor’s representations and certifications in SAM.gov will be incorporated by reference into the purchase order. Please note that NIAID requests that Section 889 representations for FAR 52.204-24 and FAR 52.204-26 be included with the Phase I response as per the 2nd bulleted item Section K page 43.

Q60: While the majority of the RFQ is focused specifically on the eCTD software the RFQ also references both the EDMS component, optional Migration and the Ongoing support of the cloud based environment. Based on the Phase I requirements it looks like the main focus is solely on the eCTD software. Is there more weight given to the total solution vs just the software product to be proposed OR is this mainly just the software that is the focus of this RFQ?

A60: NIAID declines to answer.