In anticipation of an influenza pandemic, the United States Government (USG) has identified a need for
antiviral drug acquisition by 59 eligible entities (50 U.S. states, the District of Columbia, five U.S. Territories and
three Freely Associated States of the Pacific). These entities have the option to purchase antiviral drugs through United
States Department of Health and Human Services (HHS)-negotiated contracts. Because everyone is at risk of morbidity and
possibly mortality during an influenza pandemic, it behooves entities to have a ready supply of antiviral drugs available
for timely distribution to pre-identified groups.
(The ordering period for this contract shall begin upon the Effective Date of this contract- June 29, 2006 and end twenty-four
24) months thereafter.
INSTRUCTIONS FOR USE OF CONTRACT BY STATES FOR ANTI-VIRAL DRUG PURCHASES
This document summarizes the ordering procedures for the states. It provides the states instructions and requirements for the purchase of anti-virals. Any questions about purchasing under this contract should be directed to the Contracting Officer -
HHS - Phone (202) 205-3979 or (202) 205-2978. Fax number is (202) 205-3915. Please refer to Attachment 3 to HHS Contract HHSO100200600015I and Amendment for official ordering contract process.
1. Who is authorized on behalf of the State to purchase Tamiflu?
The State Selected Ordering Officer shall review the contract and the corresponding Anti-Viral State Allocation Table to become familiar with the terms of the contract as well as the order limitations under the Federal subsidy program.
2. Once the State has determined the number of treatment courses to be ordered, how does the order get placed with HHS?
The State Ordering Officer will determine the number of treatment courses to be purchased (including purchases from local jurisdictions within the state entity). The State Ordering Officer will prepare a purchase order, with required state approvals, and forward the signed written order to the Contracting Officer at HHS - (202) 205-3979 for review and approval.
Both the State Approving Official and the Ordering Officer must sign all orders placed. The signature must appear on the actual order and shall contain a typed signature block for each individual signature.
In addition, each order shall contain the following fields:
1. Contract Number as referenced in this agreement: HHSO100200600015I;
2. Contact Information: Name of Entity's ordering officer, address, telephone number and fax number;
3. Ship To Location: Name of contact, delivery address, telephone number and fax number;
4. Invoice To: Name of contact, delivery address, telephone number and fax number;
5. Approved Quantity (courses of therapy); Unit Price and Requested Date of Delivery.
* Unit Price: The current contract price for Tamiflu is valid until 12/31/07, at which time the price will be re-negotiated with HHS for an effective date 01/01/08 through 06/29/2008.
3. How does the State know if HHS has approved the order?
The HHS Contracting Officer will confirm that the order complies with the limits of the program and notify the Contractor (Roche) and will notify the State Ordering Officer that the order can be filled. This process may take between 2 and 5 days.
HHS will provide Roche with confirmation of the approved quantity for the purchase order.
4. What happens if an order is not approved by HHS?
If any order is not approved, notice will be provided by the HHS Contracting Officer to Roche and guidance will be provided to the State Ordering Officer on the problems with the order.
5. Once an order is approved by HHS, what are the next steps to submit the approved order to Roche?
The State Ordering Officer will forward the original approved purchase order to Roche after confirmation is received from the HHS Contracting Officer. All purchase orders should be forwarded to the attention of Alex Nawotka at Roche Laboratories Inc., 340 Kingsland Street, Nutley, NJ 07110 Phone (973) 562-2027, Fax (973) 562-2739, Email Nutley.Statetamiflu@Roche.com.
6. What happens if a State places an order directly with Roche prior to HHS approval?
If Roche receives an order (order for which the entity is receiving the federal subsidy) directly from any state, Roche cannot fill the order. Roche will direct the state to forward a copy of the order to the HHS Contracting Officer for approval.
7. How does a State include state procurement terms for consideration and/or approval?
Specific terms that will be the responsibility of the States to include in the purchase order are place and time of delivery.
If the state must include state procurement terms and conditions, and/or must have the Contractor (Roche) complete W-9 forms, Contractor Certifications, and proof of Insurance, the State Ordering Officer will contact the Contractor (Roche) to negotiate those state specific terms (ensuring that any of these additional terms or requirements do not conflict with the terms of the HHS agreement) while the order quantities are being reviewed and approved by the HHS Contracting Officer.
If you have general questions regarding this Pandemic Planning Toolkit or require assistance in coordinating an antiviral program for your employees, please contact Roche:
Phone: Pandemic Planning Hotline: (973) 562-2279
E-mail: alexis.nawotka@roche.com
8. Can a state place multiple orders under the Federal Subsidy program?
A state may place multiple orders under the Federal subsidy program as long as the total combined quantities purchased do not exceed the limits determined by HHS . All orders must originate from the State Ordering Officer.
9. Can a state place multiple orders that will not be included under the Federal Subsidy program?
A state may place multiple orders that are non-subsidized. All orders must originate from the State Ordering Officer and must be forwarded to the HHS Contracting Officer for approval prior to submission to Roche. The orders must contain the elements as described in (2) above.
10. Can a state request more than one delivery location per order?
Only one delivery location will be allowed for each order.
11. Once an approved order is placed with Roche, what correspondence should be expected from Roche?
Roche will contact the State Ordering Officer with a proposed preliminary delivery schedule. Roche will also confirm the contact information, ship-to information, and invoice addresses.
The Roche Order Fulfillment Team will then use this information to open a direct account for the State's order in preparation for the delivery date.
As the delivery date approaches, the State will be contacted again to confirm location and delivery times.
12. How Does the State Determine How Much Storage Space to Prepare Prior to Delivery?
The state must ensure that adequate storage space according to Tamiflu package insert guidelines must be available prior to the final delivery schedule.
Tamiflu state pandemic dosing regimens are in bottles of 10 capsules. The bottles are packaged in cases and arranged in pallets for shipping and storage.
- Each case contains 48 bottles. Each bottle contains 10 capsules.
- Each pallet contains 5,184 bottles.
- Packaging dimensions and storage space requirements are the same for 75mg, 45mg and 30mg dosage formulations. For storage purposes, weight differences per bottle, case, or pallet between the three available dosage formulations is inconsequential.
The dimensions and weight of the bottle, case, and pallet are as follows:
Per bottle:
- Length, width, depth (cube) = 1.750" x 1.750" x 2.750" = 8.42 sq. in. = 0.0048 cubic ft.
- Weight = 0.042 lb.
Per case:
- Number of bottle per case = 48
- Length, width, and depth (cube) = L 12.625" x W 7.875" x D 6.375" = 0.37 cubic ft.
- Weight = 3 lbs.
Per pallet:
- Number of cases per pallet = 108
13. How high can pallets be stacked?
Pallets may be stacked no more than two high.
14. What is the appropriate Temperature storage range?
Store the capsules at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
15. What if delivery locations change?
The State should contact Roche as soon as a change in delivery location is known. It is preferred that these changes in location are provided prior to scheduling a final delivery date.
16. What processes should a State expect on Date of Delivery?
Depending on the quantity ordered, several trucks will arrive at the delivery location. The Roche delivery process includes security measures, and states will be expected to abide by secure procedures.
17. What is the Invoice Payment Process?
Invoices will be submitted the day of delivery. The HHS agreement requires payment within 30 days.
If the order is a subsidized order, states will receive an invoice for the state's portion of the subsidized amount ($14.43 per course, or 75% of the total contract price of $19.24 per course). HHS will be invoiced for the remaining 25% subsidy.
If the order is non-subsidized, states will receive an invoice reflecting the total contract price of $19.24 per course.
18. Does Roche accept electronic payment through EFT (Electronic Funds Transfer)?
Roche's remittance address is:
Dept 0231
P.O. Box 120231
Dallas, TX 75312-0231
States who require EFT payment must contact Roche at least two weeks prior to delivery to coordinate EFT information.
|
Tell-A-Colleague
