RFP_Amendment_No_01_(N01TR-17-2003).pdf

“CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies”

Amendment of Solicitation No.: RFP N01TR-17-2003

Amendment No.: 01

Amendment date: September 15, 2016

Due Date for Proposals: Wednesday, October 19, 2016 at 3:00 PM EDT (UNCHANGED)

Issued By:

National Center for Advancing Translational Sciences NINDS R&D Contracts Management Branch NIDA Office of Acquisition National Institutes of Health Neuroscience Center 6001 Executive Boulevard Suite 3287, MSC 9531 Bethesda, Maryland 20892-9531

* For FedEx/UPS/Courier/Hand-Delivery, use Rockville, MD 20852

Primary Point of Contact: Secondary Point of Contact:

Jeffrey Schmidt, Contracting Officer Lisa Bielen, Contracting Officer Phone: (301) 402-1488 Phone: (301) 451-7167 E-Mail: schmidtjr@mail.nih.gov E-Mail: lisa.bielen@nih.gov

NAME AND ADDRESS OF CONTRACTOR: To All Offerors

The above numbered solicitation is amended as set forth below. Offerors must acknowledge receipt of this amendment on each copy of the offer submitted. FAILURE OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE

RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter, provided each letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

PURPOSE: to respond to formal questions submitted in response to the solicitation.

All other terms and conditions of the RFP remain unchanged.

RFP No. N01TR-17-2003 RFP Amendment No. 01

RESPONSES TO QUESTIONS

QUESTION 1: Any information about solubility and stability of the peptide?

ANSWER 1: The peptide drug substance is stored at freezer conditions (-15 to -25°C) and exhibits essentially no change by HPLC/UV method for two years. The water solubility is >10 mg/ml.

QUESTION 2: What are specifications for placebo? Just look the same?

ANSWER 2: Specifications for placebo are listed in attachment 3 Sample Task Order Request for Proposal. Specifications include: 1) absence of active in the placebo as determined by HPLC/UV assay, sterility, meets requirements of current USP by membrane method;, endotoxin, particulate matter, USP 788; completeness and clarity of solution and other tests.

QUESTION 3: Stability vs pH means only solution stability or stability of the solid vs pH of pre-freeze dried solution?

ANSWER 3: Stability vs. pH in buffer solutions (pH 2-12). See Attachment 3 - Sample Task Order section F, 3)

QUESTION 4: What is the stability requirement for the freeze dried dosage form-time and temperature?

ANSWER 4: For proposal purposes offerors are to assume that the development work (Attachment 3 - Sample Task Order section F, 1-11 and particularly F, 11 results in at least one formulation that is stable for two years under refrigeration. Offerors are to monitor the formulation selected under F, 11 for up three years at 2-8°C after successful manufacture (see stability studies section of Attachment 3 - Sample Task Order).

QUESTION 5: With regard to Sample Task Order 1: The high dose (320 mg) is 8 times the low dose (40 mg). Is it desired that both doses be contained in the same size/color capsule, and that the placebo match both actives in size and color?

ANSWER 5: The two strengths of active do not have to be identical in appearance (e.g. the low dose could be filled in a MT4 capsule and the high strength filled in a MT 1 or 0). One strength of placebo is typically prepared that is in the same capsule size as the high strength product.

These products are prepared for use in Phase I single and multiple ascending dose studies. Each dose level will have 1-3 patients that receive placebo rather than active to “control” for side effects due to study conditions per se and not the drug under study. Randomization will be done by the site pharmacy.

QUESTION 6: It is essential that the anticipated dose be known, or at least the range of API to be included in the 2mL fill of solution to be freeze dried.

ANSWER 6: For proposal purposes, offerors are to assume the API has adequate solubility to deliver the anticipated dose (see Attachment 3 - Sample Task Order section F, 4). The water solubility is >10 mg/ml. Offerors may assume that the API per 2 ml of fill solution is 10-15 mg on peptide basis.

QUESTION 7: It is referenced in the RFP that “sensitive information” will be given to recipient of the contract. Can you please clarify what “sensitive information” is in the context of this

RFP?

ANSWER 7: Contractors may receive proprietary/confidential information provided by non-governmental, third parties. All such information will be appropriately marked.

QUESTION 8: Since this RFP will have multiple awards to different entities, when a specific task order comes out, will it go to multiple parties for a “bidding” process on the work required by that task order or will it automatically be awarded to one party?

ANSWER 8: See Article G.3. Task Order Procedure, paragraph c. Competitive Ordering Process.

QUESTION 9: We know that we will need to mail our proposal, but will it be permissible to also email you a PDF copy of the materials that we will be mailing to NIH as well?

ANSWER 9: The hardcopies and electronic copies must be received by the Government at the official point of receipt by the designated time to be considered timely. Proposals received by e-mail are not requested.

QUESTION 10: Will the contract be issued as a “master agreement” with multiple task orders falling under that agreement or will a new contract be issued for each task order?

ANSWER 10: We anticipate awarding multiple indefinite delivery / indefinite quantity (IDIQ) type contracts as a result of this solicitation. Task orders will be competed among the IDIQ awardees. Task Orders will be awarded to the Contractor whose task order proposal is most advantageous to the Government.

QUESTION 11: We also have a question as to what is considered a “subcontractor” for purposes of this RFP; in the normal course of business in conducting similar research projects and as required to maintain our facility as GMP compliant, we use several third parties to perform certain testing including excipient and packaging component release testing and product testing. We would anticipate as part of our work with this project that we may need to use these third parties for these specific purposes. Would this be considered a subcontractor for purposes of this RFP?

ANSWER 11: FAR Part 41.101 defines “subcontractor” as “any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime contractor or another subcontractor.”

Apply this definition to your determination.

QUESTION 12: What level of vulnerability scanning is required for private networks which are physically isolated from the internet?

ANSWER 12: Per the Vulnerability Scanning Requirements paragraph on page 29 of the solicitation, “the minimum requirement shall be to protect against vulnerabilities identified on the SAMS Top-20 Internet Security Attack Targets list.”

QUESTION 13: Will NCATS or other contracting parties require outside/remote access to internal systems or data?

ANSWER 13: Routine Government access is not anticipated. Per the paragraph title “Government access for IT inspection,” the Government reserves the right to inspect IT systems/facilities, documents, etc.

QUESTION 14: Do you require NIH Biosketches or resumes for purposes of this RFP?

ANSWER 14: Page 75 of the solicitation addresses the need for resumes. There is no specific format required.

QUESTION 15: In the RFP it is requested that we provide a summary of related activities. Can you please clarify what “commercial” agreements are? Can these include fee for service type work the University may do with industry?

ANSWER 15: Commercial agreements are typically a contract written between two entities.

Yes, these include fee for service type work a University may do with industry.

QUESTION 16: In the RFP at the top of page 77, item 6, it mentions a line for a ‘Fee’ and a line for ‘Profit’. Would that only apply in the case of a fixed-price bid? Would we give both a cost-reimbursement and a fixed-price quotation in our response?

ANSWER 16: Task orders can be issued on either a fixed-price or a cost reimbursement basis.

With respect to the Sample Task Order Requests for Proposals and subsequent “actual” Task

Order Requests for Proposals, Offerors may elect to provide either a fixed-price or cost-reimbursement proposal.

QUESTION 17: We also noted that a couple of the links that are cited in the RFP are dead links and do not work. These are:

Attachment 10: Small Business Subcontracting Plan http://www.hhs.gov/asfr/ogapa/osbdu/smallbusiness/subcontractplan.html

On the Breakdown of Proposed Estimated Cost (Plus Fee) and Labor Hours page, the Electronic Contract business Proposal excel spreadsheet link doesn’t work.

https://oamp.od.nih.gov/sites/default/files/DGS/Division/DFAS/spshexcl_Dec2012.xlsx

ANSWER 17: Use RFP Attachment 10 in lieu of the link. Use a link found at the bottom of the following website for the Breakdown of Proposed Estimated Cost (Plus Fee) excel sheet:

https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours http://www.hhs.gov/asfr/ogapa/osbdu/smallbusiness/subcontractplan.html https://oamp.od.nih.gov/sites/default/files/DGS/Division/DFAS/spshexcl_Dec2012.xlsx https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours