PSN - ATX II.pdf

PRE-SOLICITATION NOTICE

FEDERAL BUSINESS OPPORTUNITIES SYNOPSIS

Title

Procurement of Anthrax Antitoxins for the Treatment of Inhalational Anthrax

General Information

Document Type: Presolicitation Notice Solicitation Number: RFP-12-100-SOL-00026 Posted Date: 6/15/12 Classification Code: 65 – Medical, dental & veterinary equipment and supplies NAICS Code: 325412 –Pharmaceutical Preparation Manufacturing

Contracting Office Address

U.S. Department of Health and Human Services (HHS), Office of the Secretary, Assistant Secretary for Preparedness and Response (ASPR), Office of Acquisition Management, Contracts and Grants (AMCG) 330 Independence Avenue SW, Room G640, Washington, DC, 20201

Description

The Department of Health and Human Services (HHS) has the responsibility of maintaining a definitive supply of medical countermeasures – or the forward deployment of same – for use in national medical emergencies declared by the Secretary of HHS.

HHS has a requirement to acquire, store, and distribute medical countermeasures that will mitigate injuries caused by exposure to chemical, biological threat agents, physical radiologic and nuclear exposures. The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness & Response (ASPR) has a specific need for anthrax antitoxin products to treat individuals with symptomatic anthrax disease resulting from aerosol release of Bacillus anthracis (B.

anthracis) spores.

HHS through the Office of the Assistant Secretary of Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA) contemplates multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts to:

1) Manufacture and deliver to the SNS anthrax antitoxin Final Drug Product (FDP).

The FDP shall be tested and characterized, and documentation establishing compliance with cGMP and ICH requirements shall be provided. The FDP shall be delivered in a controlled and validated manner, and documentation establishing compliance with cGMP and ICH requirements shall be provided. The FDP shall be suitable for use in humans in a declared emergency or as an FDA-approved product.

2) Collection and storage of human immune plasma for the manufacture of Polyclonal

Anthrax Antitoxins as Contractor Managed Inventory. The plasma shall be tested and characterized, and documentation establishing compliance with cGMP and ICH requirements shall be provided. The plasma shall be suitable for the cGMP manufacture of Anthrax Antitoxin Bulk Drug Substance (BDS).

3) Manufacture and storage with stability testing of Anthrax Antitoxin BDS. The BDS shall be manufactured in compliance with cGMPs, tested and characterized in approved Product Specifications, and documentation establishing compliance with cGMP and ICH requirements shall be provided. The BDS shall be suitable for the cGMP manufacture of Anthrax Antitoxin FDP. The BDS shall be stored and shipped under validated conditions, and documentation establishing compliance with cGMP and ICH requirements shall be provided.

4) Manufacture and Delivery of Master Cell Banks for the production of Monoclonal

Antibody Anthrax Antitoxins to the USG. These cell banks shall be tested and characterized, and documentation establishing compliance with cGMP and ICH requirements shall be provided. The banks shall be suitable for the cGMP production of Anthrax Antitoxin Bulk Drug Substance.

The Awardee(s) selected for this acquisition will be providing the designated product, stability testing, and in some cases storage services. Successful Offerors shall provide the necessary qualified personnel, facilities, material, equipment (except Government property), and services to produce, test, formulate, fill, package, store, and deliver the anthrax immunotherapeutic. The manufacture, formulation, filling, and testing of the anthrax therapeutic shall be done in accordance with the Offeror’s Standard Operating Procedures, and all federal statutory and regulatory requirements.

Offerors shall also propose a product delivery schedule that may be subject to negotiation.

The schedule for delivery of product will be incorporated into the final contract upon award. Offerors may submit proposals for any objective for which they meet the minimum criteria.

The anticipated period of performance will be for base period of up to five years or 60 months. Additional details and requirements will be described in the solicitation.

Presoliciation Notice Objective:

This Presolicitation Notice is issued solely for informational and planning purposes only. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future.

This Presolicitation Notice does not commit the Government to contract for any supply or service whatsoever. Further, the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness & Response (ASPR) is not at this time seeking proposals, and will not accept unsolicited proposals.

A Request for Proposals (RFP) will be available electronically through the FedBizOpps on or about July 20, 2012, with proposals being due on or about August 20, 2012. Any responsible offeror may submit a proposal that will be considered by the Government. It is the offeror’s responsibility to monitor this internet site (www.fbo.gov ) for the release of this solicitation as well as any amendments. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses should be identified with the RFP number, name of firm, name of requestor, mailing address, telephone number, fax number, and email address, and should be submitted to the Point of Contact(s) identified in this notice. Multiple awards may result from this solicitation with an estimated award date of around March 2013.

Furthermore, all respondents must be registered in CCR data base, see http://www.ccr.gov and complete online Representations and Certifications at http://orca.bpn.gov.

Point of Contact

Jason Bell, Contracting Officer, Phone 202-260-1457, Email Jason.bell@hhs.gov

Darrick A. Early, Contracting Officer, Phone 202-260-0293, Email darrick.early@hhs.gov http://www.fbo.gov/ http://www.ccr.gov/ http://orca.bpn.gov/ mailto:Jason.bell@hhs.gov mailto:Jason.bell@hhs.gov mailto:darrick.early@hhs.gov