RFP Amendment 1.doc

NIAID-DMID-NIHAI2010107

Amendment #1 (Questions & Answers)

This Amendment provides questions submitted by potential offerors and the responses provided by the NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated at least weekly to add any further questions and their related responses. All potential offerors are advised to refer back to this Amendment for additional Q&A.

“MANUFACTURE AND CHARACTERIZATION SERVICES (MCS) FOR THE DEVELOPMENT OF VACCINES AND OTHER BIOLOGICS FOR INFECTIOUS DISEASE”

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, Bethesda, Maryland 20892-7612

Nicole Gordon, Contract Specialist

Please also cc:

andersondj@niaid.nih.gov Deborah Anderson, Team Lead

Offerors must acknowledge receipt of the final posting of Amendment #1 on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals HAS NOT been extended.

REVISED: Deadline for Receipt of Questions: August 15, 2011

THE FOLLOWING PAGES PROVIDE ANSWERS CONCERNING A NUMBER OF INQUIRIES WE HAVE RECEIVED FOR THE ABOVE NUMBERED ACQUISITION:

Question 1 Will manufacturing and development capabilities be required for Drugs, Devices, and Biologicals? Please provide clarification.

The first mechanism to narrow the required capabilities is the title of the NIAID-DMID-NIHAI2010107 Solicitation that is: “Manufacture and Characterization Services (MCS) for Vaccines and Other Biologics for Infectious Diseases”

A second mechanism to narrow the required capabilities can be found in the definitions in Attachment 3, pages 2-3 that state:

Vaccines – An antigenic preparation used to render an organism immune to an infectious disease by inducing or increasing immunity for prophylaxis and/or therapy. Vaccine products include but are not limited to synthetic peptides, recombinant proteins, nucleic acids, viral-like particles, vector-based vaccines, as well as live, modified, and/or attenuated bacteria, viruses, and other organisms.

Vaccine Components – An antigen-enhancing substance (e.g. adjuvant) or a delivery system (e.g. needle free dermal patch) that is used during dose administration to enhance the immune response of a vaccine.

Other Biologics – Therapeutic preparations made from living organisms or the components of living organisms and are most likely regulated by CBER. Biologics include but are not limited to allergenics; antitoxins; blood and blood products; and cellular and gene therapy products. For the purposes of this contract, challenge material for non-clinical, preclinical, and clinical trials will also be included in the definition of biologics.

Question 2 ARTICLE H.15 (page 22) INFORMATION AND PHYSICAL ACCESS SECURITY, has a number of requirements (i.e., mandatory training for all employees, IT security certificate and accreditation, and several plans) that seem to be in support of the overall contract. Is it your intent that these requirements will be performed under Task Order 1? If so, are the associated costs to be incorporated into pricing for Task Area 1 and expected to be a part of the Government’s estimated hours (307) for this task?

The offeror should incorporate costs into Task 1 that are required to support the overall contract. However, costs associated with specific Task Orders should be incorporated specifically into those task orders.

Question 3 ARTICLE M.7 (page 86) TECHNICAL EVALUATION FACOTRS, indicates that protection of human subjects is to be an evaluation factor while Article H.1 indicates that human testing is not required. Please clarify.

Research involving human subjects shall not be conducted under this contract. As a result, protection of human subjects should not be an evaluation factor.

Question 4 Section 5 (page 58) RESEARCH INVOLVING VERTEBRATE ANIMALS states, “The following five points must be addressed in a separate section of the Technical Proposal titled "Vertebrate Animal Section" (VAS)…” The Table of Contents template provided at Attachment 4 contains no section titled “Vertebrate Animal Section”. Should Section 7: OTHER CONSIDERATIONS, D. Care of Live Vertebrate Animals be changed to D. Vertebrate Animal Section?

“Vertebrate Animal Section” (VAS) may be considered interchangeable with “Care of Live Vertebrate Animals.”

Question 5 Animal testing is contemplated for release testing, stability studies, and IND-enabling pre-clinical studies. Does the government anticipate:

1. Studies to support licensure under the Animal Rule;

Animal rule may be a route to licensure for a subset of products/projects/specific task orders. However, animal rule is not a component of release testing.

2. ABSL-4 aerosol challenge studies;

Aerosol challenge studies would not be considered as part of a routine potency release test for a vaccine or other biological including challenge material.

3. if so, with what agents;

Not applicable since aerosol challenge studies are not within scope of this contract.

4. And if so, with what species?

Not applicable since aerosol challenge studies are not within scope of this contract.

Question 6 In ATTACHMENT 3 (page 10) Statement of Work, (a) Will the government please characterize the relationship that will exist between NIAID, the contractor and the vendor(s) who are subject to feasibility studies and audits? For example, will the contractor establish subcontracts with these vendors for completion of required services or will the government be responsible for assuring vendors’ cooperation and timely participation to include payment(s) to vendors; are contractor – vendor NDAs anticipated, or will the non-disclosure terms of the contract be sufficient? (b) How will the government resolve disputes between the contractor and vendor concerning findings and results of feasibility assessments and/or audits?

Relationship between NIAID, contractors, subcontractors, and vendors can be clarified by the Statement of Work, Attachment 3, Page 1:

“The Contractor shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order.”

The Contractor may also perform audit services for NIAID at vendor sites identified by NIAID. The contractor will not be responsible for vendor site costs associated with the audits or feasibility assessments.

Question 7 In ATTACHMENT 3 (page 11) Statement of Work, (a) If a product sponsor is not NIAID, how does the government anticipate obtaining product sponsor approval of IND-enabling preclinical study plans, designs and testing results?

NIAID will be the “Contract and Project Sponsor” responsible for all final decisions based in part on input from product sponsors. There is no direct relationship between product sponsor and contractor.

(b) What form of input and level of authority will non-NIAID product sponsors have concerning selection of subcontract performers or consultants for design and performance of IND-enabling preclinical studies?

Both NIAID and non-NIAID product sponsors may submit lists of potential subcontractors, vendors, and consultants for consideration by the contractor. However, “The Contractor shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order.”

Question 8 ATTACHMENT 4 (page 2) states, “Afterwards, offerors should describe similar technical capabilities for other vaccines, vaccine components, and other biologics not specified in the sample task orders.”

Is it correct to interpret this instruction to mean required descriptions of similar SOW technical capabilities for those not specified in the sample task orders are to be provided only in the Technical Proposal in appropriate subsections of the following table of contents sections:

2.B.1. cGMP Manufacturing and Related Activities, 2.B.2. Process Development and Related Activities, 2.B.3. Feasibility Assessments and Audits, and

2.B.4. Regulatory Activities and Documentation?

If this is incorrect, please clarify which sections of the table of contents are to also address these required descriptions?

Offerors may describe similar SOW technical capabilities either in the following or similar format:

Section 2 Technical Approach

A. Task Area 1 - Admin…

1 Sample Task Order 1 response including organizational experience, etc.

2 Similar technical capabilities for Task Area not specified in Sample Task Order.

B. Task Area 2 - cGMP….

Sample Task Order 2 response including organizational experience, 1 etc.

2 Similar technical capabilities for Task Area not specified in Sample Task Order.

C. Task Area 3 – Process Develop…

3 Sample Task Order 2 response including organizational experience, etc.

4 Similar technical capabilities for Task Area not specified in Sample Task Order.

D. Task Area 4 – Feasibility and Audits

a. Sample Task Order 4

b. Sample Task Order 5

c. Similar technical….

Question 9 The proposal instructions indicate multiple items be addressed for each Sample Task Order (STO) that may be redundant between sections, such as the Project Management and Administration information. To better utilize page limitations would it be acceptable for offerors to include this information in one STO, and then refer back to that STO in subsequent STO sections, or does the Government desire to have the information repeated in each STO?

Offerors may include common information in one sample task order and then refer back to the specific page and section in subsequent sample task orders. However, differing levels of work and associated costs specific to each sample task order should be clearly identified.

Question 10 In the interest of uniform pricing assumptions, will the government provide: (a) locations for each of the two sites to be audited; (b) days duration, including travel days, of each audit; and (c) days duration of the site visit(s) in B.10 (ATTACHMENT 4 (page 34))?

Assume each site requires travel of approximately 600 miles one way. Assume 2 days for travel, 2 days for on-site visit, and 3 days for preparation and report writing.

Question 11 ATTACHMENT 6 (page 1) states, “No later than one month following award, the Contractor shall provide a plan describing the specific procedures it will employ to safeguard any proprietary data and other information obtained or generated under this contract, including the restricted-access files that are obtained or generated under this contract, including the restricted-access files that are required”. (a) Should this requirement be included in ARTICLE C.2 REPORTING REQUIREMENTS? (b) Is it your intent that this requirement will be performed under Task Order 1? If so, are the associated costs to be incorporated into pricing for Task Area 1 and expected to be a part of the Government’s estimated hours (307) for this task?

The plan should be included in ARTICLE C.2.

The Offeror should incorporate costs into Task Order 1 that are required to support the overall contract. However, costs associated with specific task orders should be incorporated specifically into those task orders.

NIH-NIAID- DMID-NIHAI2010107

Amendment #1 (Q&A) – 1st Posting