Published April 24, 2026
Q&A
Q1.
We respectfully inquire whether New York State would consider adding an additional line item to the pricing and bid for an FDA-approved 3 mg naloxone nasal spray for evaluation alongside the 4 mg strength?
A1.
At this time, we are only considering distribution of 4-mg naloxone.
Q2.
Section 4: If two 4 mg naloxone manufacturers submit the same contract price, how will an award be determined?
A2.
In the event of a tie, the bidder that offers intranasal naloxone products with the longest shelf life will be selected. If both bidder’s naloxone products have the same shelf-life, then the winner will be selected via a coin flip.
Q3.
Section 2: Will expiry date past 30 Months be weighted any differently for award?
A3.
No, except for when a tie breaker is needed.
Q4.
Section 2: Will different packaging configurations be considered? For example, bulk packaging?
A4.
Yes, we are open to bulk packaging options as an additional offering.
Q5.
Section 7.10: Is the Office of Addiction Services and Supports willing to amend the contractor insurance requirements to reflect those that are appropriate for a product purchase agreement vs a service agreement?
A5.
The insurance requirements included in the IFB were established in accordance with New York State contracting guidelines and reflect NYS OASAS’s assessment of the risks associated with this procurement.At this time, NYS OASAS is not proposing any revisions to the insurance requirements. Bidders should base their proposals on the requirements as stated in the IFB.
Q6.
Sections 1.3.A.2 page 4 - Please confirm that, for purposes of demonstrating experience under Section 1.3.A.2, “shipment volumes of more than 120,000 units per month to multiple requestors” refers to bidder experience over at least two continuous years in accepting and fulfilling naloxone orders under a direct contract with a state for direct purchasing from a drug manufacturer, with shipments in one or more months under such direct contract totals more than 120,000 units from multiple separate in-state requesting entities and/or to in-state ship-to locations, consistent with the requirements outlined in Sections 2.1(A)-(C) and 2.2.B.
A6.
This experience should be specific to the volume of shipments for a single entity, in this case the NYS OASAS, and the winning bidder’s demonstrated ability to fulfill that level of volume—and more if necessary—to support any initiatives that may arise. This requirement is not intended to reflect cumulative shipments across all accounts managed by the winning bidder. Rather, it is focused on the bidder’s capacity to meet high-volume monthly demand for a single account, including the ability to distribute 120,000 units or more per month to a multitude of requesters across all regions of the state, should the need arise.
Q7.
Sections 2.1.A-B page 7; Sections 1.3A page 4 - How will OASAS verify the representations in Section 1.3, Mandatory Requirements, and Attachment 14, Bidder Qualification Attestation, in particular with respect to the "shipment of volumes of more than 120,000 units per month to multiple requestors" (Section 1.3(A)(2); Attachment 14 first bullet) and the delivery requirements (Section 1.3(A) and (C); Attachment 14, bullets 1-4).
A7.
NYS OASAS will only accept bid proposals from Bidders who attest and certify that they meet all of the following minimum requirements. By signing Attachment 14 – Bidder Eligibility Attestation the bidder is attesting, certifying and confirming that the statements listed are accurate and true.
Q8.
Sections 1.3B / 2.1 pages 4 & 7 - Please clarify whether the Department requires intranasal naloxone to be manufactured and assembled in the United States from U.S. and other imported components, and whether there are any requirements or preferences related to country of origin for the active pharmaceutical ingredient.
A8.
The distributor must adhere to all U.S. Food and Drug Administration standards and practices related to the manufacturing and assembly of life-saving naloxone products.
Q9.
Sections 2.2, 2.8.2, 4 pages 7, 8, 9 & 11 - How will OASAS verify the representations in Section 1.3, Mandatory Requirements, and Attachment 14, Bidder Qualification Attestation, with respect to online ordering and tracking portal (Section 1.3(D); Attachment 14 (4th and 8th Bullet)?
A9.
See response to Q7.
Q10.
Section 6.1X page 15 - The IFB notes the ability to make awards in excess of the posted amount. Please clarify whether such awards would be made to the same vendor or whether additional vendors may be awarded under such circumstances.
A10.
It is the intent of NYS OASAS to make one (1) award from this procurement. Any resulting award will allow for the purchase of Naloxone on an as needed basis, with no guarantee of any purchases, and will be issued as a Purchase Authorization (PA). NYS OASAS anticipates that the initial PA will be for up to $8.0M, however NYS OASAS reserves the right to increase the PA amount if additional Naloxone is needed contingent on all required approvals.
Q11.
Section 1.3.H. Data Security page 5; Section 7.27 page 27 - Please confirm whether the Data Security provisions are limited to those in Section 7.27, Technology Provisions. If not, please provide the additional requirements.
A11.
Per New York State security requirements and policies, all controls will be determined based upon the information classification and identity assurance level for this application. Essentially FISMA Low, Moderate or High will be determined during the SSDLC process.
Q12.
Will NYS OASAS permit offerors to redline terms and conditions for which the offeror cannot agree to?
A12.
We permit vendors to submit redlined terms and conditions for review. All proposed changes will be evaluated internally, and final determinations will be made by our Legal Office in accordance with New York State and NYS OASAS requirements.
Q13.
Can NYS OASAS share utilization data over the past 1-3 years?
A13.
NYS OASAS makes naloxone distribution data available through its website at https://oasas.ny.gov/harm-reduction-supply-distribution.
Q14.
Can NYS OASAS confirm how many delivery points there will be as well as share the addresses of those delivery locations?
A14.
Due to the scale and variability of the program, the NYS OASAS cannot provide a definitive number or comprehensive list of delivery locations. Currently, there are approximately 650 unique users, many of whom utilize multiple delivery addresses, resulting in potentially thousands of delivery points across New York State. Bidders are expected to have the operational capacity and confidence to fulfill distribution needs at this scale and across a wide geographic area.
Q15.
How many deliveries per week are estimated?
A15.
Estimated delivery volume may range from dozens to thousands of deliveries per week. This variability is influenced by factors such as time of year, seasonality, and current initiatives undertaken by the NYS OASAS. Bidders are expected to have operational capacity and flexibility to meet fluctuating demand and fulfill delivery needs at any scale, at any given time.
Q16.
Are there any clauses or provisions that dictate payment terms or is that negotiable?
A16.
Payments by the State shall be made upon the completion of the services outlined in the Scope of Work to the satisfaction of NYS OASAS. The Successful Bidder must submit invoices, not more often than monthly, to NYS OASAS with required documentation for services performed.Payment for invoices submitted by the Successful Bidder shall only be rendered electronically unless payment by paper check is expressly authorized by the Commissioner, in the Commissioner’s sole discretion, due to extenuating circumstances. Such electronic payment shall be made in accordance with ordinary State procedures and practices. Please refer to Section 5 of IFB 25019 for more information regarding electronic payments and procedures.
Q17.
Will NYS OASAS permit pricing adjustments to account for annual manufacturer price increases?
A17.
The price bid under this IFB shall be the maximum price payable by NYS OASAS during the term of the Contract. If, during the Contract term, the Contractor offers or provides a lower price for the same product to another governmental entity, the Contractor shall automatically extend such lower price to NYS OASAS, effective on the date the lower price becomes available.
Q18.
Would NYS OASAS consider removing following verbiage in the Attachment 2- Fiscal Proposal: "The Contractor certifies that the price offered is no higher than those charged to any other federal, state, or local governmental entity for the same or substantially similar product and quantities." or amending it to "The Contractor certifies that the prices offered are in line with fair market value"?
A18.
No.
Q19.
Are there any specific NDC's that NYS OASAS is looking for or once the contract is awarded, can the awardee offer different brand/generic NDC that aligns with the product and max offered price?
A19.
The NYS OASAS requires the 4 mg intranasal naloxone formulation as the only approved and recommended product at this time. No other formulations are currently being utilized. However, the NYS OASAS is open to consideration of different brands or generic equivalents, provided they meet all applicable U.S. Food and Drug Administration guidelines and align with NYS OASAS requirements.
Q20.
What is your eligibility for contract pricing? If so, can you provide what contracts that your organization is eligible for and which NDC's apply?
A20.
For contract pricing, please refer to Attachment 2-Fiscal Proposal.
Q21.
Would NYS OASAS consider a higher minimum order quantity specified by the offeror in their proposal (per 2.1F the min is currently 12 units)?
A21.
No, the NYS OASAS will not consider a higher minimum order quantity specified by the offeror. The minimum order requirement is one case of naloxone consisting of 12 units, with each unit containing two intranasal doses. There is no maximum order quantity. However, it is essential to the framework of this initiative that the awarded vendor has the flexibility and capacity to fulfill orders at or below a single case, based on the specific needs of entities and communities across New York State.
Q22.
Section 2.1B states that "The Successful Bidder shall manufacture, distribute, directly ship, and track naloxone orders on behalf of NYS OASAS." Is the intent of NYS OASAS to only award this requirement to a manufacturer or could this language be amended to accommodate wholesalers who distribute naloxone on behalf of the manufacturer?
A22.
The NYS OASAS intends to award a manufacturer who can manufacture, distribute, directly ship, and track naloxone orders on behalf of NYS OASAS.
Q23.
Due to ever-changing market dynamics, as a distributor/wholesaler partner, are we allowed to bid multiple items and prices?
A23.
The NYS OASAS requires that each bidder submit a single bid. Multiple items or pricing options from the same distributor within one solicitation are not permitted.
Q24.
Section 1.3 Mandatory Qualifications, C. Delivery Requirements, Item 3. Requires that the bidder “provide next-day delivery at no additional cost to NYS OASAS when operationally required.” How frequently does NYS OASAS anticipate asking for overnight delivery of the product? Please provide the number of times next-day delivery was requested in the most recent 12-month period. How many of the next-day delivery requests were for palletized quantities requiring freight deliveries versus standard parcel deliveries? What were the unit quantities shipped in each of the next-day deliveries during the most recent 12-month period? What are the anticipated next-day delivery shipments and quantities for the upcoming year starting on September 1, 2026?
A24.
This information is not available.
Q25.
Section 1.3 Mandatory Qualifications, D. Online Order and Tracking Portal: Are configuration-based solutions acceptable, or is custom-built functionality expected?
A25.
The NYS OASAS requires a system that meets all parameters outlined in the IFB. Configuration-based solutions are acceptable as long as they fulfill these requirements. The NYS OASAS reserves the right to review proposed systems prior to award.
Q26.
Section 1.3 Mandatory Qualifications, D. Online Order and Tracking Portal Item 3.i.: Is the State’s expectation that individual entities (naloxone distribution partners) will have the ability to create their own accounts? Or does the state only want this capability at the NYS OASAS ordering portal administration level to create and manage account creation on behalf of individual entities? Does the state want to assign any account approval authority beyond the ~15 state account administrator positions?
A26.
It is the expectation of the NYS OASAS that individual community entities be able to apply for a naloxone ordering account via the existing online web portal. We do not anticipate more than 15 NYS OASAS account administrator positions.
Q27.
Section 1.3 Mandatory Qualifications, D. Online Order and Tracking Portal Item 3.ii.For the 1,000-account onboarding requirement, will NYS provide clean, validated data in a standard format, or will data cleansing be expected from the vendor?
A27.
The NYS OASAS will provide clean data in a standard format.
Q28.
Section 1.3 Mandatory Qualifications, D. Online Order and Tracking Portal: Should NYS administrators have global visibility across all provider accounts, or be scoped by region/entity?
A28.
Global Data
Q29.
Section 1.3 Mandatory Qualifications, D. Online Order and Tracking Portal Item 3.iii.: Can you provide more details on the assistance that the Supplier should plan to provide during high volume account requests? Is this data entry support only
A29.
Whenever the NYS OASAS requires assistance during periods of high-volume account requests, the winning bidder must be prepared to support the full process. This includes, but is not limited to, data entry, account creation, order placement, shipping, logistics, and coordination from the initiation of the order through to delivery. The awarded vendor must be capable of providing assistance for any step involved in the ordering and fulfillment process to ensure that services and supplies are delivered to end users without disruption, even during peak demand periods.
Q30.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Can NYS provide specific security framework requirements for the naloxone ordering and reporting portal (e.g., alignment to NYS ITS policies, NIST, etc.)? Are there explicit encryption or audit log standards that must be met for the naloxone portal?
A30.
The vendor must be compliant with all NYS Security Policies and Standards. Please refer to the NYS Security Logging Standard (NYS-S14-005) and the NYS Encryption Standard (NYS-S14-007) or any subsequent published documentation/update.
Q31.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding compliance framework and evidence, can NYS confirm whether compliance with NYS ITS standards (e.g., NYS-S14 series) must be formally certified for the naloxone ordering and reporting portal, or if industry certifications (e.g., SOC 2 Type II, ISO 27001) are acceptable as supporting evidence?
A31.
The vendor must complete appropriate security reviews which are tailored towards the NYS Security Policies and Standards which should certify the solution. If industry certifications are available and provided to NYS OASAS, these are not to be used as alternate methods of a security review. The security review(s) and vulnerability scans, per the NYS Secure System Development Life Cycle (NYS-S13-001), must be adhered to.
Q32.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding compliance framework and evidence for the naloxone ordering and reporting portal, what level of documentation or attestation is required from vendors to demonstrate alignment with NIST 800-53B and NYS ITS policies?
A32.
There is no specific documentation or attestation that is required from bidders. However, the bid submission in response to this IFB will serve as a bidder’s attestation that they will align with all NYS ITS policies, as applicable.
Q33.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding security logging and monitoring for the naloxone ordering and reporting portal, does NYS require direct access to vendor security logs, or are summarized/auditable reports sufficient?
A33.
The vendor should provide summarized, auditable reports when requested by NYS OASAS or, in the event of an incident, the vendor must notify NYS OASAS within an NYS OASAS defined timeframe.
Q34.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding security logging and monitoring for the naloxone ordering and reporting portal, are there specific requirements for log format, delivery method, or frequency beyond standard reporting (e.g., API access, SIEM integration)?
A34.
Details for log format and delivery methods should meet the NYS security requirements for logging.
Q35.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding security logging and monitoring, in the event of a security incident, what are the expected notification timelines and reporting requirements?
A35.
NYS ITS/OASAS recommends immediate notification for High incidents, within 24 hours for Moderate and Low incidents. The severity must be in alignment with the NYS Cyber Incident Response Standard (NYS-S13-005)
Q36.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding encryption standards for the naloxone ordering and reporting portal, is the strict use of FIPS 140-2 / 140-3 validated cryptographic modules mandatory, or are equivalent industry-standard encryption controls acceptable?
A36.
The vendor must meet or exceed NYS requirements and provide the "equivalent industry-standard encryption controls" for New York State.
Q37.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding encryption standards for the naloxone ordering and reporting portal, are there any specific key management or key rotation requirements vendors must adhere to?
A37.
The vendor must be compliant with the NYS Encryption Standard (NYS-S14-007) (Section 4.3 Key Management) and all NYS Security Policies and Standards.
Q38.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding data access and auditability, what level of audit trail detail is expected to be made available to NYS for the naloxone ordering and reporting portal (e.g., user-level activity, administrative actions, data changes)?
A38.
The vendor must comply with the NYS Security Logging Standard (NYS-S14-005). Logging and auditing must be completed for all user roles and actions performed within the system
Q39.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding data access and auditability for the naloxone ordering and reporting portal, does NYS require real-time visibility into audit logs, or is on-demand access sufficient?
A39.
See response to Question 33.
Q40.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding data housing and hosting for the naloxone ordering and reporting portal, are cloud-hosted solutions acceptable, and if so, are there approved or preferred cloud environments?
A40.
Yes cloud-hosted solutions are acceptable. NYS OASAS utilizes the requirements and controls outlined in NYS security policies regarding cloud environments and does not have an approved or preferred environment. However, all individuals and infrastructure must be working within/hosted within the Contiguous United States (CONUS) and must be compliant with the NYS Security Policies and Standards. No, there are no approved or preferred cloud environments. Please refer to IFB section 7.27 Technology Provisions for further information.
Q41.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding security assessments and reviews, does NYS require vendors to undergo periodic security assessments, audits, or penetration testing, and if so, at what frequency?
A41.
This answer is defined in the various NYS Security Policies and Standards. As of this writing, periodic risk assessments must be performed annually. Vulnerability scans must be performed periodically determined by NYS OASAS and the sensitivity of the data stored/processed/transmitted in the solution. See the following references:
NYS-P03-002: Information Security Policy
- Section 4.14 Vulnerability Management
- "3. Where an SE has outsourced a system to another SE or a third party, vulnerability scanning, and penetration testing must be coordinated."
NYS-P03-002: Information Security Policy
- Section 4.4 Information Risk Management
- Bullet 1: “Any system or process that supports SE business functions must be appropriately managed for information risk and undergo information risk assessments, at a minimum annually, as part of a secure system development life cycle.
Q42.
Section 1.3 Mandatory Qualifications, H. Data Security; Appendix D 1.42 Compliance with NYS Information Security Policies and Standards: Regarding security assessments and reviews for the naloxone ordering and reporting portal, will NYS conduct its own security review or require access to vendor systems for validation?
A42.
In the future, should an award be made, the vendor must provide sufficient documentation and supporting documentation to NYS OASAS to perform the appropriate security review(s), per the NYS Secure System Development Life Cycle (NYS-S13-001), if requested by NYS OASAS.
Q43.
Section 2.2 Ordering, Approval, and Tracking System: Is the state going to create accounts for buying entities? Or does the state want the entities to create accounts and have approval authority to make the accounts active? Will NYS directly create/manage accounts in the portal, or should the vendor provision accounts based on NYS-approved submissions? Is a self-service registration with NYS OASAS staff approval workflow acceptable?
A43.
Yes, the state is going to create accounts for buying entities. NYS will create accounts in the portal.
Q44.
Section 2.3 Reporting and Tracking, Section 2.8 Service Level Agreement: Are standard downloadable reports sufficient, or is real-time dashboard access required?
A44.
Real-time reporting must be available at all times through the online platform. This may be provided via a downloadable Excel spreadsheet or a real-time dashboard. Users must be able to request and download data in real time without requiring approval from the distributor.
Q45.
Section 2.3 Reporting and Tracking: Which data elements need to be included in each type of report? Can each of these reports be available for NYS OASAS to download in a PDF format? Or is the expectation that NYS OASAS would have dynamic report-building capabilities within the portal? Or is the expectation that reports will be emailed to the NYS OASAS staff (based on a state-provided report recipient list)?
A45.
All reports must include all related information of orders placed. NYS OASAS staff must be able to retrieve this information in real time through the portal at any time. Reports may also be available for download in PDF format, or more comprehensive reports may be provided via download or by request through email. Real-time access to all information from order creation through delivery—including entity, requester, and shipping details—must be available to NYS OASAS staff without restriction.
Q46.
Section 2.5 Customer Support, C.; 2.8 Service Level Agreement (SLA): What are the expected SLAs for after-hours support (response versus resolution)?
A46.
In the event that NYS OASAS staff require assistance outside of standard business hours, contact information—such as email, phone, or messaging system to a monitored line—must be available. It is not expected that shipping or order fulfillment occurs 24 hours a day, nor that staff are continuously on call to process orders. However, in rare circumstances where off-hour, evening, or weekend requests are raised as a priority, a monitored line must be available to facilitate communication.
Q47.
Section 2.5 Customer Support, C.: “After-hours and weekend availability must be provided to support emergency initiatives, surge distribution needs, or other time-sensitive public health responses.” Please specify the frequency of after-hours and weekend support required over the past 12 months.
A47.
Over the past 12 months, 12-20 times. However, this service must be available at any time as required by the NYS OASAS.
Q48.
Section 6.3 Proposal Security: Will any portion of the bid evaluation utilize artificial intelligence? If so, what processes are in place to protect trade secrets and/or redacted information?
A48.
Artificial Intelligence will not be used in the evaluation of bids received for IFB 25019.
Q49.
If there is a conflict between terms of Appendix A and Appendix D, which governs?
A49.
Appendix A takes precedence over Appendix D.
Q50.
Section 7.3 MWBE and EEO Requirements (Attachment III), Business Participation Opportunities for MWBEs: Since the goals are set to 0%, what portion(s) of this requirement can be disregarded (i.e. which portions of Attachment III are not considered relevant and required when goals are 0%)
A50.
Although the MWBE is set at 0%, Form 4, Form 5 and Form 6 of Attachment III are required by the successful bidder before execution of the Purchase Authorization.
Q51.
Is Attachment V necessary since this project does not involve personally identifiable information or protected health information?
A51.
Attachment V is required by the successful bidder before execution of the Purchase Authorization.