Amendment 1 2nd Posting- 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 (2nd posting – Questions 10-22)

Issue Date: January 24, 2011

Effective Date:

Proposal Due Date:

January 24, 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.

Question 10:

Section L.1.b.4. Resumes, on page 48 of the solicitation states resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.

In addition to the above requirement, may offerors provide resumes of the other proposed personnel for this bid as part of an Appendix that is not included in the 200-page limitation?

Response to Question 10:

Offerors may provide additional resumes in proposals at their discretion, but all information submitted must comply with the page limits as stated in attachment 1: “Not to exceed 200 pages (inclusive of all attachments and appendices).”

Question 11:

Section L.4.a. Sharing Research Data of the solicitation states that the contract is expected to generate research data and requires a plan for data sharing. Please confirm whether it will be required for this contract. If so, can offerors include the data sharing plan in the “Other Considerations” section of the proposal?

Responses to Question 11:

A data sharing plan is required for NIH research and research support contracts. The location of the plan within the proposal is at the offerors’ discretion.

Question 12:

Attachment 1, Packaging and Delivery of Proposal, (pg. 2) states that hard copies of the Technical and Business Proposals are to be unbound.

Please confirm if 3-ring binders are acceptable for the Technical and Business proposals hard copies?

Response to Question 12:

3-ring binders are discouraged. Rubber bands or easily removable clips are acceptable.

Question 13:

With regard to the font size and spacing under Attachment 1, Section C, Formatting and Layout (pg. 1) as stated below:

“Documents submitted using Adobe .pdf shall be submitted using a .pdf searchable format.”

• Type size must be 10 to 12 points.

• Type spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.’

Given that a proportional type font, such as Times New Roman or Arial, will not always yield 15 characters per inch, may a proportional font and point size be used that will give, on average, 15 characters per inch, for example, Times New Roman, 11 point?

Response to Question 13:

A standard proportional type font that yields an average of 15 characters per inch is acceptable.

Question 14:

Attachment 6 (pgs 3-5) in the “RMC Functions columns”, states that offerors are to identify the costs for the four computer-based/automated systems (i.e. RMC Regulatory Health Authority Data Management and Reporting System; Protocol-Specific Site Registration System; SECD Data Management and Reporting System; and Electronic System for Tracking Safety Reports). Pg. 11 of Attachment 6 (under Item 6 – Estimate of Effort and Budget Presentation) requires “a supplementary annual budget representing only those costs associated with performance of the automated systems requirements…” Please clarify whether this requirement pertains only to systems costs such as software and licensing, or should offerors also include the costs of necessary Information Technology (IT) labor broken down for these four systems.

Response to Question 14:

Offerors must provide all proposed costs for performance of the tasks indentified under the supplementary budget requirement, inclusive of software and licensing and necessary Information Technology labor.

Question 15:

Attachment 6 – under “Other Regulatory Support” item d. – toll-free telephone line (pg. 9). In addition to the toll-free line surcharge and usage costs, we assume we are also to propose costs for the teleconference access service and international access fees for any country without 800-service. Please confirm.

Response to Question 15:

This assumption is correct.

Question 16:

Attachment 6 – Item 4 – Storage (pg. 10): Please provide added information on the volume of materials to be stored for Regulatory Submissions and SECDs. Although 800 linear inches of ACCO press folders is cited and provides some information, what is the approximate volume of the 300 and 650 binders noted (or the number and size of file cabinets currently housing these materials)? Also – beyond these storage requirements noted for items to be housed at the contractor’s facility, is there a need for any off-site document storage?

Response to Question 16:

The binders on average are standard 4-inch binders. Offerors are to use their expertise and experience to propose the necessary storage requirements for binders of this size and amount. The Government has not identified a need for off-site document storage in this requirement.

Question 17:

Attachment 3 – Option 2: Increase in Level of Effort (pg. 29) and Attachment 6, Item 6, Estimate of Effort and Budget Presentation (pg. 11): Can the government provide additional information for Option 2, Increase in Level of Effort? Should the offeror assume an increase in effort equally across the base requirements of the Statement of Work, or should the increase be assumed across particular Statement of Work area(s)?

Response to Question 17:

Offerors should assume an increase in effort equally across the base requirements of the SOW. Section L, 1., d., (pg. 39) level of effort states, “The Government’s estimated requirement…is 11,440 direct labor hours per year.” Attachment 6, Item 6, states, “The Government estimates the effort to perform the base requirements…to be approximately 5.50 full time equivalents (FTEs) per year.” For this solicitation, the Government used 2080 hours for the determination of a single FTE. The note under Attachment 3, Option 2 states, “Each increment should represent a 25% increase of effort over the number of hours proposed for the base period/year.” The Government’s estimates for a single increment of Option 2 may therefore be calculated as 2,860 direct labor hours or 1.375 FTEs. Offerors are reminded that the Government’s estimates of effort are provided for assistance in preparing proposals and are not considered restrictive.

Question 18:

Option 3, Provision of Accessibility to a DAIT-wide clinical research information system Attachment 6 (pgs. 11-12): Please clarify the following:

a. Is the contractor expected to continue working in their database and share defined data elements with the DAIT-wide database via an electronic mechanism such as a web service (or alternate data sharing methods)?

b. Does this Option include development of the modules related to this work that will be part of the DAIT-wide database?

c. Does this Option include migration of data from the proposed systems to the DAIT-wide system?

Response to Question 18:

a. The Government expects that contractors would interact with the DAIT-wide system using primarily web-based interfaces. Some automated interfaces supporting electronic data exchange may be provided; but such interfaces would be expected to use industry standards such as XML.

b. The contractor will not be expected to develop modules for the DAIT-wide database itself. However, it is reasonable to expect that the contractor will always have some type internal systems and functions that support their activities and that they may wish to implement features in their systems to more efficiently support interactions with the DAIT-wide system.

c. Yes, if the Government exercised this option, migration of existing data would be a required task. We would expect the contractor to export data and documents in industry standard formats that are well documented, correct, complete, and consistent so that information could be reliably imported into the DAIT-wide system.

Question 19;

What information can be provided about the current software used for this contract?

Response to Question 19:

See responses to questions 5c, 5d, and 9 above.

Question 20:

Option 4, FDA Requirements for electronic submission of IND/IDE document (Attachment 6, pg. 12): When should it be assumed that Option 4 will be implemented (i.e., for which period(s) should costs be proposed)?

Response to Question 20:

Offerors should assume the potential implementation of Option 4 during the initial year and each option year of the contract.

Offerors should provide an annual budget to show the cost of the performance of Option 4 each year of the contract.

Question 21:

Is there a reading room available for this solicitation containing SOPs and other relevant materials?

Response to Question 21:

No.

Question 22:

What information can be provided about the current project staffing? Specifically, what is the total FTE count for the current support to DAIT Office of Regulatory Affairs for trials conducted under all Networks funded by DAIT NIAID as well as for trials conducted by individual PIs funded by DAIT through a non network mechanism?

Response to Question 22:

All relevant information concerning the Government’s estimated effort requirements are contained within the solicitation (see references cited in Response 17 above).

In response to questions from multiple potential offerors requesting further detailed information about the cost assumptions provided in the RFP:

Due to the unknowns inherent in the research which may result in clinical sites requiring regulatory support, DAIT is unable to provide further detailed or exact numbers beyond the assumptions already provided in Attachment 6 (regulatory submissions, protocols, clinical trials, travel/meeting participants, country-specific site locations, etc.) for cost proposal purposes. All offerors have equal access to the technical and cost assumptions provided in the RFP for proposal preparation purposes and should rely upon their knowledge and expertise in providing regulatory support services in developing a proposal (technical and business) that best represents their understanding of the requirements. All proposals will be evaluated according to the award factors described in Section M of the RFP.