Amendment 1 - RFP-NIAID-DAIT-NIHAI2010031.pdf

Amendment #1 to RFP-NIAID-DAIT-NIHAI2010031 “NIAID Division of Allergy Immunology and Transplantation:

Regulatory Management Center”

Amendment to Solicitation No.: RFP-NIAID-DAIT-NIHAI2010031

Amendment No.: 1 (1st posting)

Issue Date: January 11, 2011

Effective Date:

Proposal Due Date:

January 11, 2011

February 22, 2011, at 3:00 p.m. (EST)

Issued By: David T. Lisle Contracting Officer

NIH/NIAID

Office of Acquisitions 6700 B Rockledge Drive Room 3112 Bethesda, Maryland 20892-7612

Point of Contact: Albert Nguyen, Contract Specialist nguyenal@niaid.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 HAS NOT been extended. Offerors must acknowledge receipt of this amendment. Failure to receive your acknowledgement of this amendment may result in the rejection of your offer.

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 this Amendment # 1 for additional Questions & Answers.

Question 1:

Section F of the SOW states:

“The contractor will provide assistance to ensure compliance with GMP, GCP and GLP.”

Please provide a definition of the anticipated assistance mechanisms and whether they include on site compliance audits.

Response to Question 1:

The anticipated assistance mechanisms can vary depending on the specific compliance issue to be addressed. The contractor will be expected to provide the required skills and expertise to identify what must be done to address the issue. The “for cause” actions may require a visit to a site or vendor and audit of the facility for GMP, GCP or GLP requirements.

Examples:

1. Site visits for: (i) qualification of: a clinical site’s GMP facilities for manufacture of a patient-based cellular product that will be administered in the trial; (ii) qualification of a contract lab for conduct of a GLP toxicity study required for the initiation of a clinical trial; (iii) evaluation of serious GCP violations.

2. Site visits for site training on specific GCP, GLP or GMP issues that have been identified during course of a trial.

What is not intended by this section of the SOW is the routine GCP monitoring site visits required during the conduct of a clinical trial.

Question 2:

Attachment 5, page 8, (Technical Proposal Instructions) states:

“Provide proposed Audit SOPs describing procedures to prepare for and comply with the findings of audits and for implementing corrective/remedial actions resulting from audits by DAIT-designated entities and Regulatory Health Authorities.”

Does DAIT want Audit SOPS submitted with the proposal, or within 90 days as noted in the SOW, and if they are to be submitted, are the SOPS to be included in the total page count?

Response to Question2:

Offerors should submit generic, non-DAIT specific SOPs for dealing with FDA and client audits with the initial proposal and within the page limit. The intent is that the offerors will submit existing SOPs and the length of the SOPs will be manageable with respect to overall page limit.

Question 3:

Attachment 6, page 11 states:

“The Government estimates the effort to perform the base requirements of SOW (Year 1 and Option 1 - additional years 2 thru

10) to be approximately 5.5 FTEs per year “and “Offerors must provide an annual budget for the performance of all base SOW requirements. Additionally, for analysis purposes offerors must provide a supplementary annual budget representing only those costs associated with the performance of automated systems requirements as specified in the SOW tasks; 3.B.1, 3C, 3D, 3E."

Are the supplementary budgets above and beyond the budget/FTE allotment for the base requirements?

Response to Question 3:

The supplementary budget is included within the budget/FTE allotment for the base requirement and is being requested for analysis purposes.

Question 4a:

Attachment 3, page 30 Option 4 (Requirements for Electronic Submission of IND/IDE Documents) states:

“..the Contractor shall provide for electronic submission of IND and IDE documents when such requirements are implemented by the FDA.”

Is it correct to assume the government intends to exercise Option 4 only if FDA were to mandate electronic submission of INDs/IDEs and, therefore, the government expects Option 4 to be implemented independently of the RMC Regulatory Health Authority Data Management and Reporting System (3.B.1)?

Response to Question 4a:

Yes –the assumption described above is correct

Question 4b:

Assuming the government’s intent is to exercise Option 4 only upon an FDA requirement for electronic INDs/IDEs, should prospective offerors include in the base requirement cost estimates for IND/CTA/IDE preparation, submission, and maintenance (ref: Attachment 3 pp. 6-8) only in paper format?

Response to Question 4b:

Attachment 3 pp 6-8 describes IND/CTA/IDE preparation, submission and maintenance. The prospective offeror should include in the base requirements, cost estimates for paper format only.

Question 5a:

Attachment 3, Section B.1 (RMC Regulatory Health Authority Data Management and Reporting System), page 9, and Attachment 3, Section D.1 (SECD Data Management and Reporting System), page 13, both state:

“Establish, operate, maintain and manage, using commercially available software, a state-of-the-art computer-based system at a central facility for…” [The offeror] interprets the definition of centralized facility to be such that the entity, [the offeror], serves as that facility responsible for housing all documentation and electronic systems as opposed to individual sites, DAIT, or a single facility.

Please verify the correctness of this interpretation.

Response to Question 5a:

A centralized facility is defined as a single physical facility. The intent is to allow for an audit of all documentation and electronic systems at a single physical facility (not housed at a DAIT facility or at multiple individual sites).

Question 5b:

The RFP states on p.64 that “Contractors will provide all property necessary for contract performance” and on p.65 it states that “No Government Furnished Property is offered for this acquisition.” Therefore, [the offeror] interprets the requirements such that the central facility is not required to be on-site at DAIT. Please verify that this is a correct interpretation.

Response to Question 5b:

The interpretation as stated above is correct.

Question 5c:

On page 65, the RFP states that “No Government Furnished Property is offered for this acquisition.” Therefore, [the offeror] assumes that the Government does not own a COTS/GOTS product(s) currently in use for this work. [The offeror] further assumes that DAIT does not have any existing COTS/GOTS product(s) in use on the current contract to perform the tasks described in sections B.1, D.1, or E that they wish to continue to use. Please verify that that these assumptions are correct. If these assumptions are not correct, please identify the names of the current system(s) the government desires to continue using as part of this opportunity, and clarify specifically what the government means by “establish” as stated in B.1 and D.1?

Response to Question 5c:

The assumptions are correct.

Question 5d:

Due to requirements of commercially available software, [the offeror] interprets this to mean there will be no customization to the software code to meet any DAIT specific requirements. [The offeror] further interprets this to mean that the standard reports that are available as part of the COTS software package will be used for reporting purposes. Please verify the accuracy of these statements and specifically describe any variances to [the offeror’s] interpretation.

Response to Question 5d:

Modifications to reports or even the creation of new reports would generally not be considered customized software provided:

The report generator is part of the core product, is easily accessible, and well documented. Alternatively, customized reports could be created using a third-party product, provided the data structures used by the tool are completely accessible and documented.

Question 6a:

Attachment 3, Section L: Facilities, Equipment and Other Resources states:

“Provide all facilities, equipment and other resources necessary to carry out the requirements of the contract. “, but the list of requirements does not include facilities, equipment, and resources for Option 4. Should offerors assume that description of facilities, hardware, software, and other resources for implementation of electronic IND/IDE submissions should not be part of the base period portion of the proposal and would, instead, constitute part of Option 4 implementation plan described on page 30, Attachment 3?

Response to Question 6a:

The interpretation as stated above is correct

Question 6b:

Does the government intend for the Option 4 infrastructure (including hardware, software, processes, staffing, etc.) to be built on-site at DAIT, or is the intention for the offeror to implement electronic submission services using the offeror’s e-sub infrastructure?

Response to Question 6b:

If Option 3 is exercised prior to exercise of Option 4, then the offeror would be expected to utilize the DAIT-wide clinical information system in the implementation plan for Option 4. If Option 3 is not exercised prior to exercise of Option 4, then the offeror would be expected to implement electronic submission services using the offeror’s e-sub infrastructure.

Question 7:

Attachment 3, Page 6, Statement of Work Section A states:

“Providing translations of submissions to Regulatory Health Authorities outside the U.S. and providing translations of communications from such Regulatory Health Authorities, as needed;” Additionally, the listing of DAIT-supported clinical research programs and contracts (Attachment 7 pp.1-28) suggests coverage for only two countries, namely U.S. and United Kingdom. Which regulatory agencies other than the US FDA and UK MHRA does the Division anticipate to be included in this deliverable?

Response to Question 7:

In Attachment 3 Page 4, under B. “Scope of Clinical Sites” it states “Includes domestic and foreign clinical sites (examples:

clinical sites in Canada, Australia, the European Union, Mexico and Asia).” Sites in any of these areas may require submissions to the appropriate Health Authorities and translations as needed.

Question 8:

Attachment 6, page 2 Cost Assumptions, IND/CTA and IDE Preparation and Submission; and IND/CTA and IDE Annual Reports. The assumptions for new activities for contract period of performance states “…an average of 10 new US INDs/IDEs per yea…and an average of 50 IND/CTA and IDE annual reports per year.”

What is the breakdown of the number of INDs/CTAs and IDEs, both for original INDs/CTAs and IDEs as well as for the purpose of annual reporting?

Response to Question 8:

NIAID is of the opinion that there should not be a significant cost variance between the different types of submissions and offerors should base proposal budgets on the information already included in RFP Attachment 6.

Question 9:

The RFP contains several references to a requirement of "commercially available" system and software. The references appear in Sections 3.B.1, 3.D, and 3.E (on pages 9, 13, and 18 respectively) of the Statement of Work in Attachment 3 of the RFP.

Since the term "commercially available" as it refers to systems and software has multiple definitions in the industry, can the Government be more specific regarding its requirement? Specifically, does the "commercially available" requirement refer to underlying software components as well as pre-packaged commercial off-the-shelf systems? Further, can the Government specify its requirements in terms of licensing and transferability?

Response to Question 9:

The central intent of requiring commercial and off-the-shelf software is to avoid the risks and costs associated with interfacing with and migrating data from proprietary, undocumented, and/or unsupported systems. Within the context of the RFP, "commercially available" refers to hardware and software that:

1. Is pre-packaged and off-the-shelf (i.e. not developed specifically or solely for use under the RMC contract);

2. Can be purchased or licensed from one or more vendors with a pre-existing presence in the marketplace;

3. Is available to, and used by, other governmental and private industry users;

4. Is regularly updated with bug fixes and enhancements;

5. Has maintenance and support available from the vendor and/or third-parties.

If the cost of licenses and maintenance are included the RMC contract, they should be transferrable to the Government.