SPECIAL NOTICE
A -- W911QY-13-S-CDP2
- Notice Date
- 11/1/2013
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY141CDP2
- Archive Date
- 1/30/2014
- Point of Contact
- Richard Totten, 301-619-2446
- E-Mail Address
-
ACC-APG - Natick (SPS)
(richard.totten1@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- SYNOPSIS: This Request For Information (RFI) is posted to conduct market research for capabilities from potential sources for development of an autoinjector drug-delivery device(s), or an already FDA-approved (cleared to market) drug delivery device that will deliver therapies useful against nerve agent poisoning. The particular therapies of interest are the nerve agent antidotes atropine and pralidoxime chloride, as well as the anticonvulsants midazolam and diazepam. The Department of Defense (DoD) is seeking industry interest to manufacture these antidotes individually, in self-contained delivery devices designed for automatic self- or buddy-intramuscular administration by military Service Members. Respondents are invited to provide materials related to their capabilities to fulfill ALL or ANY of the requirements listed below. Respondents should provide whether their level of interest and current capability is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. If candidates are interested in teaming with other sources, please include in your response an authorization to release your company's name, area of interest, and POC information to be made available on a public website. All proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201(e). This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. BACKGROUND: Therapeutic pharmaceuticals against chemical, biological, radiological and nuclear (CBRN) warfare agents are required to support the Joint Forces across a range of military operations. As such, the DoD has a need for developing and fielding systems that provide treatment for exposure to CBRN agents. The Medical Countermeasure Systems-Chemical Defense Pharmaceuticals (MCS-CDP) Joint Product Management Office is responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against chemical, radiological and nuclear threats. The current MCS-CDP portfolio includes nerve agent therapeutics, pretreatments and prophylactics at varying stages of clinical development, including FDA-approved drugs. The DoD currently procures the following therapies for nerve agent poisonings through the Directorate of Medical Materiel, Defense Logistics Agency Troop Support: Diazepam, as a component of the Convulsant Antidote for Nerve Agents (CANA). Each autoinjector contains 10 mg of diazepam in 2.0 mL. Each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% ethyl alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative. The CANA is a self-contained unit for diazepam injection. The U.S. Army Office of The Surgeon General (OTSG) sponsors the CANA New Drug Application (NDA), NDA 20-124, approved in December 1990. The National Stock Number for the CANA product is NSN 6505-01-274-0951. Atropine sulfate for injection, as a component of the AtroPen. Each 2 mg atropine autoinjector dispenses 1.67 mg atropine base (equivalent to 2.0 mg atropine sulfate) in 0.7 mL sterile, pyrogen free solution containing glycerin, phenol, citrate buffer and Water for Injection. The pH range is 4.0-5.0. The National Stock Number for the AtroPen is NSN 6505-00-926-9083 Pralidoxime chloride or 2-PAM for injection. Each autoinjector contains 600 mg pralidoxime chloride in 2.0 mL of a sterile, pyrogen free solution containing 20 mg/mL benzyl alcohol, 11.26 mg/mL glycine in Water for Injection, USP. The pH is adjusted with hydrochloric acid. The pH range is 2.0-3.0. The pralidoxime chloride autoinjector is a self-contained unit designed for self- or buddy-administration by military personnel. The National Stock Number for the product is NSN 6505-01-125-3248. Atropine and 2-pralidoxime in a dual chamber autoinjector, as components of the Antidote Treatment, nerve Agent Autoinjector (ATNAA). Each ATNAA autoinjector contains 2.1 mg atropine in 0. 7 mL solution and 600 mg pralidoxime chloride in 2 mL solution in separate chambers as sterile, pyrogen free solutions for intramuscular injection, sequentially, through a single needle. The U.S. Army OTSG sponsors the ATNAA New Drug Application (NDA), NDA 21-175, approved in January 2002. The National Stock Number for the ATNAA product is NSN 6505-01-362-7427. The DoD intends to procure the following therapy for nerve agent poisoning in the future: Midazolam, as part of the Advanced Anticonvulsant System (AAS). Each autoinjector should contain 10 mg midazolam in 2.0 mL sterile, pyrogen free solution for intramuscular injection, through a single needle. AAS is a self-contained unit designed for self- or buddy-administration by military personnel. AAS is currently in advanced development at MCS-CDP OBJECTIVE: Currently, MCS-CDP is seeking capabilities from potential sources for development of an autoinjector drug-delivery device(s), or an already FDA-approved (cleared to market) drug delivery device that will deliver these nerve agent poisoning therapies. These life-saving antidotes and anticonvulsants are used in conjunction with the pretreatment, pyridostigmine bromide (PB). System requirements include individual drug delivery platform(s) containing diazepam, midazolam, atropine, or pralidoxime chloride in the doses currently procured by the DoD. The dual deliver of the drug components atropine plus 2-pralidoxime in an autoinjector is the subject of a separate RFI, Solicitation Number: W911QY-14-S-CDP1. The Service Member-carried device must be administrable by personnel in Mission Oriented Protective Posture 4 (MOPP-4) over-garments and mask, to a casualty in MOPP-4. The delivery device platform(s) and drug must be stable at operationally relevant temperatures to include temperature extremes experienced by Service Members in the field. The desired storage conditions for each antidote in its drug delivery device is USP Controlled Room Temperature (i.e., stored at 25 C [77 F], excursions permitted to 15-30 C [59-86 F]; Keep from Freezing, Protect from light), or be such as to provide reduced logistical burden than the currently fielded antidotes. In addition, the shelf life should eventually achieve 5 years at controlled room temperature. As such, MCS-CDP is seeking information on current industry capabilities from interested entities in the following areas: (1) Description of company's proposed drug delivery platform(s), to include: General background information, product name and description, as well as pertinent development efforts needed to encompass delivery of a single drug (diazepam, midazolam, atropine, or pralidoxime chloride) in a single autoinjector. Appropriateness of proposed drug delivery device(s) for military field-use, including: a.Portability of the proposed drug delivery platform(s) by the Warfighter and combat medic b.Ease of self- or buddy administration by personnel in Mission Oriented Protective Posture (MOPP) 4 protective ensemble c.Ability of the proposed drug delivery platform(s) to administer drug product through MOPP-4 d.Suitability for use across a wide range of temperature and operationally relevant environmental conditions e.Suitability for long term storage at controlled room temperature f.Compatibility of known pharmaceutical products in the proposed drug delivery platform(s), as well as its components, under long-term storage conditions Summary of existing manufacturing capabilities, annual and surge capacity, and place of manufacture. Any intellectual property concerns to include your company's rights and ability to sell or license any intellectual property as well as your company's interest in selling or licensing the intellectual property. Proprietary information should be marked as described in the paragraph below. (2) Description of company's experience with FDA regulatory activities leading to product approval/licensure, to include: a.Ability to manage activities related to the development of an IND application and New Drug Application (NDA) submissions and supplements. Describe experience with submissions in an electronic Common Technical Document (eCTD) format. b.Engaging in meetings with the FDA and preparation of pre-meeting information packets. c.Comparative bioavailability and bioequivalence studies d.Stability testing at controlled room temperature and identification of temperature excursion limits (3) Submit quote mark Draft Development Plan Outline quote mark describing, proposed preclinical, clinical studies, and CDRH device studies/protocols envisioned to be necessary to manufacture the above drugs in a drug delivery device suitable for FDA approval. SUBMISSION INSTRUCTIONS: All written responses must be received within fifteen (15) days of issuance of this RFI. Submissions should: (1) Use Microsoft Word or Adobe Portable Document Format (PDF); (2) Be sent to the POC identified below by email only; (3) Be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (4) Include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address (es); and (5) Not exceed 10 single sided pages in total (not including cover page and cover letter). Material that is advertisement only in nature is not desired. Please address responses to this notice to the Government Contract Specialist, Richard Totten: richard.w.totten2.civ@mail.mil. Please designate a company point of contact (telephone, address, and email). All questions regarding this RFI must be in writing and emailed. No telephone inquiries will be accepted. The North American Industry Classification Systems (NAICS) for this notice is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) with a size standard of 500 employees. Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please ensure that your registration in the System for Award Management (SAM) is up to date prior to submission of your response. Further information and registration information may be found at the following website: https://www.sam.gov/portal/public/SAM/ Contracting Office Address: US Army, Army Contracting Command, Natick Contracting Division, Fort Detrick, ATTN: Richard Totten, 1564 Freedman Drive, Fort Detrick, Maryland 21702. Point of Contact: richard.w.totten2.civ@mail.mil
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