Norethindrone 5mg Tablet (VA-25-00005551)

MARKET RESEARCH QUESTIONNAIRE NORETHINDRONE ACETATE TABLETS Company Name:

I am conducting market research for the procurement of Norethindrone Acetate Tablets for the Department of Veterans Affairs (VA), Department of Defense (DoD), Indian Health Service (IHS), Bureau of Prisons (BOP), and Federal Health Care Center (FHCC).

This procurement will result in a national mandatory requirements contract for the above agencies. Other companies with the same/similar product will be blocked out for ordering; therefore it is our goal to award lower than FSS/Open Market prices on the resultant national contract based on purchases of a committed volume. This product will be awarded for the base year and all option years included in the solicitation. Please provide a response to the following:

1. Is your Company able to meet the following minimum requirements:

National Drug Code (NDC): Offerors shall provide a separate and distinct eleven-digit NDC number unique to the offeror (e.g., 00012-3456-78) for each product proposed. The first five numbers of the eleven-digit NDC number for each product proposed shall identify the offeror. Additionally, the successful offeror/contractor s label with its unique NDC shall be the only label on the product. Contractors shall not affix their label over another label on the product. Does your company have a unique NDC (Labeler Code)?

If the offeror is not the manufacturer of the offered items, the offeror shall submit a letter of commitment from the manufacturer to the offeror which will assure the offeror a source of supply sufficient to satisfy the Government's requirements for the contract period.

Name of Manufacturer:

Would you be able to provide a letter of commitment from the manufacturer of the offered drug?

Pharmaceutical Prime Vendor: All Ordering Activities under the Department of Veterans Affairs and Department of Defense acquire their pharmaceutical requirements through their Pharmaceutical Prime Vendor Program (PPV). The contractor shall ensure that chargeback agreements with the PPVs have been executed with sufficient time to permit the PPVs to begin timely distribution of Government orders, if an award is made. Does your company currently have a business-to-business agreement with the PPVs?

d. Under NAICS code 325412, is your company size (check one): Large Business

Small Business

e. If a small business, does your company manufacture (measure, weigh, mix, and compound) at least 50% of the product offered?

f. Is the offered end product U.S end-made or designated end made product?

g. Can your company meet the following product, bottle size and usage: ITEM DESCRIPTION PKG SIZE (Tablets per Bottle) TOTAL EST ANNUAL USAGE (Bottles) 1 Norethindrone Acetate 5mg Tablet 50 13,202 2 . Is your Company interested in submitting a response to a solicitation?

3. As this is a national standardized contract, our preference is for a base plus four option years to provide our customers continuity and consistency of product by allowing long term committed purchases of your product. If interested, please indicate Base year and how many Option periods, not to exceed 4.

4. If an award were to be made based on the above requirements, would your company be able to begin supplying the product in the estimated quantities within 60 days of the contract award date?

5. If your company is not interested in participating, please respond with the reason why. This aids our market research for future procurements.

6. VA intends to require in the solicitation that proposed products are in unit of use package sizes for the line item (50-count bottles). VA defines unit of use package sizes as follows:

Unit of use package sizes must contain a child proof closure (safety cap) and a bottle with a minimum required size of 120cc volume. The safety cap must not exceed the diameter of the bottle. The bottle must have a cylindrical body and minimum of 5.75 circumference. The bottle must fit a label with a dimension of 5.25 x 2 . The 0.5 additional space is required to keep the bar code exposed and/or allow for the display of the expiration date and lot number. Please indicate if your company can provide the products above meeting these packaging requirements.

7. If your company could supply the products in this solicitation in 50-count bottles, but could not meet the unit of use requirements outlined above, please use the space below to indicate the reason and any details. This information is important as it helps the Government consider possible product issues when developing the solicitation.

If you could provide your responses by August 1, 2024, it would be greatly appreciated. Please contact me if you have any questions.