Amendment__2.pdf

Amendment #2 to NIAID-DAIT-NIHAI201800018 CIVICs Statistical, Data Management and Coordination Center (SDMCC)

Amendment to Solicitation No.:

NIAID-DAIT-NIHAI201800018

Amendment No.: 2

Issue Date: October 15, 2018

Effective Date:

Proposal Due Date:

October 15, 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 (Unchanged).

USECTION 1- MODIFICATIONS TO THE SOLICITATION

ARTICLE F.3. LEVEL OF EFFORT, a., is hereby updated as follows:

a. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, 1. GENERAL INFORMATION, e.

LEVEL OF EFFORT, is hereby updated as follows:

e. LEVEL OF EFFORT

The Government's requirement for the work set forth in the Statement of Work of this solicitation is 5,200 direct labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor Category Labor Hours Professional 3,120 Other Professional 1,040 Support 1,040

USECTION 2- 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: Under Article F.3 – Level of Effort (LOE) (RFP pg. 15) – 5,200 hours is stipulated as the required LOE.

However, under Section L.1.e (pg. 50), the text states 5,020 (while the table below sums to 5,200). Please confirm that 5,200 is the LOE requirement.

Response to question 1: The Level of Effort (LOE) requirement is 5,200 direct labor hours per year. Please see Section 1 as part of this Amendment.

Question 2: Under Article F.3, the LOE range is stated as “not less than 5,200 nor more than 5,200” (in other words, exactly 5,200 hours). Satisfaction of LOE requirements typically is stated as a range (in our NIH contract experience), for example with text as follows: “The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.” Please clarify whether a range of LOE (versus an exact number of hours) will satisfy the requirements of a resulting contract.

Response to question 2: Please see Section 1 as part of this Amendment.

Question 3: Under the Statement of Work (SOW), Technical Requirement #4 (CIVICs Program Coordination Services) (Attachment 3 pgs. 7-9), several references are made regarding the need to prepare, provide, develop and implement, and/or make available SOPs (see subsection references cited below). Please provide further clarification on the party(ies) who will be implementing these SOPs, such as:

(a) the clinical sites that will be conducting the operations/protocols; and/or

(b) the site monitoring entity for report preparation; and/or

(c) the successful offeror/CRO for activities and support.

If NIAID is not expecting all 3 of the above entities, please further clarify.

Response to question 3 (SOW references below):

SOW 4.b.i: Prepare and make available to the CIVICs program a data submission user’s manual and standard operating procedures (SOPs).

Answer: The successful offeror/CRO for the SDMCC is primarily responsible for this activity

SOW 4.b.vi (Clinical Study Initiation and Training of Clinical Site Personnel). iii: Prepare and provide to clinical site personnel SOPs covering all such policies, procedures and requirements, and working with NIAID and clinical site staff to identify site-specific training needs.

Answer: The successful offeror/CRO will work with the CIVICs awardees and NIAID staff to develop and implement these SOPs.

SOW 4.b.vii (Clinical Trail Standard Operating Procedures). i: Develop and implement SOPs governing all aspects of the support to be provided, e.g., all types of visits, descriptions of each aspect of clinical trial conduct and clinical site operations to be reviewed, detailed work instructions, etc.; and ii: Develop and implement SOPs to provide monitoring report and other related data to NIAID utilizing the NIAID CRIS.

Answer: The successful offeror/CRO will work with the CIVICs Clinical Core and Vaccine Centers and NIAID staff to develop and implement these SOPs.

Question 4: SOW Requirement #4.c (pg. 9), requires “Development, maintenance, and revision of a Quality Management Plan to ensure that Quality Control and Assurance metrics are met for all activities conducted by the SDMCC.” Please clarify the scope of this requirement - does it relate to services under the entire contract (i.e. all the SOW Technical Requirements), or just the activities under Requirement #4 - CIVICs Program Coordinating Services?

Response to question 4: The Quality Management Plan includes all SDMCC activities outlined in the SOW: 1.

Statistical Design and Analysis; 2. Data Management and Analysis; 3. CIVICs Program Data Access and Resource Sharing; and 4. CIVICs Program Coordination Services).

Question 5: Under “Uniform Cost Assumptions” (UCAs) (Attachment #5, Section 3.1, Technical Cost Assumptions), Item #7 states “Assume two independent QA audits for the duration of the contract period of performance.” Should offerors assume that the successful contractor will conduct those audits, or is that text pertaining to audits that would be conducted of the contractor by another party? Please clarify, as this item is not referenced in the SOW.

Response to question 5: This text pertains to audits that will be conducted of the contractor by another party (e.g., NIAID or it’s designate).

Question 6: Under UCAs (Attachment #5, Section 3.2, Travel), Item 2.b. references training workshops for clinical site staff, requiring 4 presenters. Please confirm that the contractor is responsible for travel costs for the presenters only, and that site staff travel will be handled by the sites/other entities.

Response to question 6: This text pertains to travel costs for the successful offeror/COR presenters only, not CIVICs clinical site staff.

Question 7: Under the above UCA for Travel, Item 2.c. references arrangement of site visits to CIVICs contractor sites.

Please clarify:

(a) the locations of these sites for cost proposal estimating purposes;

(b) whether such visits are to occur each year; and

(c) whether this is the only travel the offerors should propose to the sites; or for example, should added travel be proposed for CIVICs site training (for SOW Item 4.b., pg. 7-8). If added travel to sites should be proposed for training, please provide applicable UCAs (e.g. frequency, duration) for cost estimation purposes.

Response to question 7: These site visits will occur for each CIVICs prime contractor sites. For cost purposes, please assume the following:

• Five (5) Prime contractor sites: 3 Vaccine Centers; 1 Clinical Core; and I Vaccine Manufacturing/Toxicology Core.

• Up to two (2) visits to each prime site over the life of the contract

• SDMCC offerors may propose additional travel, including any additional training (beyond the workshop), to the CIVICs prime sites at their discretion and with a clear justification.

Question 8: We are seeking to confirm the requirement for a query tool for tracking and reporting of CIVICs (@ SOW 3.b, pg.

6). It seems that the query data tool may be duplicative of the requirement to provide the same data to other publicly-accessible databases and query tools (@ Item b., directly above on the same SOW page). Can the Government expand on the specific tracking and reporting requirements in SOW Section 3.b to differentiate that query function from existing tools referenced in Section 2?

Response to question 8: The requirement in SOW 3.b refers to query of the database/portal for internal reporting/tracking of CIVICs-related activities, including data sets, resources, meta-data for the CIVICs investigators or NIAID staff. The requirement in b. directly above SOW 3.b refers to the SDMCC either assisting the CIVICs sites or directly transferring CIVICs-generated scientific data sets/meta-data to public repositories/databases. The SDMCC is not responsible for making the CIVICs-generated scientific data available to the public via the portal developed under SOW3. b.

Question 9: Within the first 90 days post-award, does selected awardee need the ATO to be completed for the FISMA moderate system i.e., does NIAID need a fully functional system with public access within the first 90 days of the contract?

Response to question 9: Within 90 days of contract award, the system/portal described in SOW 3 needs to contain the following functionalities, with the understanding that the system/portal will be updated on a regular basis and be able to grow in capability/capacity as the CIVICs program develops:

• Browse capabilities: collected data from CIVICs sites;

• Query capabilities: the data to address tracking and reporting requirements of CIVICs;

• Community access to information about results and resources generated by the CIVICs program, including pointing the public to CIVICs data sets housed in NIAID-supported or other databases, publications lists, meeting updates, vaccine candidates in clinical testing, etc.; and

• Adopt and implement FAIR data-sharing guidelines in data management, access and sharing solutions that enable and ensure interoperability and subsequent dissemination through NIAID-supported or other public repositories and knowledgebases.

Requirements for ATO within 90 days of award will be discussed during negotiations with meritorious offerors.

Question 10: Bullet # “3. CIVICs Program Data Access and Resource Sharing”, under Technical Requirements (page 6 of Attachment 3: Statement of Work), the text states:

a. Within 90 days, “browse collected data from CIVICS sites” - does this include the metadata and/or the raw data collected?

Response to question 10a.: This requirement includes both the meta-data and experimental/clinical data generated by the CIVICs sites

b. Within 90 days provide “community access”- does this include outside public sources or the internal CIVICS community only?

Response to question 10b.: Community access refers to the broader scientific (and educated lay) community outside of CIVICs

c. Within 90 days, what functionality would be needed to satisfy “interoperable and subsequent dissemination through NIAID supported or other public repositories and knowledge bases”? Does this requirement include packaging and shipping data to these public repositories?

Response to question 10c.: This requirement is linked to SOW 2. Data Management and Analysis and refers to the ability of the SDMCC to be interoperable with (i.e. transfer/upload, combine, and/or compare relevant meta-data, clinical and experimental data) and based on data standards developed by other NIAID-supported databases (such as CRMS, ImmPort, IEDB, FluDB/IRD/ViPr), and other public repositories.

Question 11: Please clarify interoperability requirements with existing NIAID systems – what level of interoperability is expected? For example - should it be a data exchange enriched with standard metadata either in real time or batch transfer? Are we required to provide operational interoperability (common functionality and look and feel) and/or technical interoperability -common technology and technical environment?

Response to question 11: Please see the answer above in regards to interoperability -which is primarily a technical interoperability. The offeror should describe how they will achieve this interoperability in their proposal.

Question 12: Is there a recommended/preferred platform by NIAID for this work (e.g. ImmPort)?

Response to question 12: No. The offeror should describe how they will achieve the SOW requirements in their proposal.

Question 13: Is there a preferred EDC system for the clinical trial data management? Is CRMS the preferred option, or other proposed solutions are allowed for consideration?

Response to question 13: No, however, Management of clinical trial and human challenge data must include Data links to and interoperability with the NIAID Clinical Research Management System (CRMS:

https://ncrms.niaid.nih.gov) to provide enrollment and study status updates.

Question 14: On p.50, LOE requirement indicates 5200 hours, does that requirement cover the work over the course of the entire project (stays consistent from year to year), or additional hours are anticipated to be required in the outer years when scaling up is expected to occur with the additional data entered into the system?

Response to question 14: Offerors shall propose LOE options at 5200 hours for all years (including out years) as options. Please see ATTACHMENT 3: STATEMENT OF WORK, Option(s), Option 7 - 41: Increase Level of Effort

Question 15: Could you provide a more detailed description of the differences in requirements for the professional and other professional listing in the LOE specifications on p.50 of the RFP?

Response to question 15: Offerors are to propose their own labor category mix within the Labor Categories as part of their response.

Question 16: Do references in the data management section to “integration,” in the statement of work, actually mean making data available and participating in standardization discussions, or the requirement also encompasses integration of the various data sources and systems?

Response to question 16: SOW 2. Data Management and Analysis states that the system must be interoperable with and based on the data standards developed to date by the NIAID-funded ImmPort (www.immport.org), the Immune Epitope Database and Analysis Resource (www.iedb.org), the Bioinformatics Resource Centers (BRCs:

www.fludb.org), the Centers of Excellence for Influenza Research and Surveillance (CEIRS) (http://www.niaidceirs.org/), Clinical Research Management Systems and other relevant NIAID-designated databases/repositories. The SOW also states that the SDMCC may participate in ongoing development efforts and data and meta-data standards efforts of the ImmPort, IEDB, CEIRS, BRCs and other relevant databases/repositories for diverse data types and clinical metadata generated by the CIVICs program to ensure interoperability and data sharing. Systems/solutions proposed by the offerors should be interoperable with existing NIAID-funded systems so that CIVICs datasets, information, etc. can be provided to these “external” resources.

Question 17: Does NIAID anticipate releasing answers to questions on a rolling basis, or only once after November 14? If the latter, when are the answers expected to be released in advance of the November 29 proposal due date? Will the government contemplate extending the due date to provide sufficient time to address answers to questions?

Response to question 17: A due date extension is not anticipated. We request that all questions pertaining to the RFP be submitted to the Government no later than November 19, 2018, 3:00pm EST (Unchanged). Any Amendments will be posted accordingly.

Question 18: Page 50, Section L, e. Level of Effort. Is the estimated 5,020 labor hours the total hours per year or for the entirety of the seven-year contract?

Response to question 18: The estimated 5,200 labor hours is the total hours per year.

Question 19: Can the government confirm that there is a vaccine manufacturing system in place through the manufacturing system contract and that the Contractor will not be expected to implement one through this contract?

Response to question 19: The Vaccine Manufacturing and Toxicology Core is being solicited through a separate solicitation: Component B of Research Area 3 (Collaborative Influenza Vaccine Innovation Centers (CIVICs)), described in Amendment 1 to HHS-NIH-NIAID-BAA2018. The SDMCC will develop/maintain a data management system (SOW 2. Data Management and Analysis) that includes vaccine manufacturing, formulation and toxicology metadata and data collection and tracking (the data and meta-data to be supplied by the Vaccine Manufacturing and Toxicology Core).

Question 20: Can the government confirm that a biospecimen tracking system will be provided by NIH and that the Contractor is not required to implement one through this contract?

Response to question 20: As part of SOW 4. CIVICs Program Coordination Services, the SDMCC will develop/maintain a system that includes access to “a record of the location and status of all samples (animal and human) reagents, and vaccines collected or generated by the CIVICs program to facilitate sharing/distribution across the CIVICs program and with the broader research community”.