SOURCES SOUGHT
A -- Medical Countermeasure Systems-Chemical Defense Pharmaceuticals(MCS-CDP) REQUEST FOR INFORMATION for manufacturing capability for nerve agent antidotes in an autoinjector.
- Notice Date
- 10/18/2013
- Notice Type
- Sources Sought
- 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
- W911QY-14-S-CDP1
- Response Due
- 11/4/2013
- Archive Date
- 12/17/2013
- Point of Contact
- Jennifer, 301-619-8401
- E-Mail Address
-
ACC-APG - Natick (SPS)
(jennifer.s.bassett.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- W911QY-14-S-CDP1 MCS-CDP REQUEST FOR INFORMATION Nerve agent antidotes in an autoinjector SYNOPSIS: The purpose of this Request For Information (RFI) is to conduct market research for manufacturing capability for the nerve agent antidotes atropine and 2-pralidoxime, in a single autoinjector for 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 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 Department of Defense (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 nerve agent antidotes atropine and 2-pralidoxime as components of the Antidote Treatment Nerve Agent Autoinjector (ATNAA), the replacement for the two injector MARK-1 nerve agent antidote kits. 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 ATNAA is a self-contained unit designed for self- or buddy-administration by military personnel. The National Stock Number for the ATNAA product is NSN 6505-01-362-7427. ATNAAs are supplied through the Directorate of Medical Materiel, Defense Logistics Agency Troop Support. The U.S. Army Office of The Surgeon General (OTSG) sponsors the ATNAA New Drug Application (NDA), NDA 21-175, approved in January 2002. OBJECTIVE: Currently, MCS-CDP is seeking capabilities from potential sources for development of an autoinjector drug-delivery device that will simultaneously or sequentially deliver the nerve agent antidotes atropine and 2-PAM. These life-saving antidotes are used in conjunction with the pretreatment, pyridostigmine bromide (PB), and an anticonvulsant. System requirements include a drug delivery platform containing the drugs atropine and 2-PAM. The delivery device platform and antidotes must be stable at operationally relevant temperatures to include temperature extremes experienced by Service Members in the field. The storage conditions must be equal to conditions indicated for the ATNAA (i.e., stored at 25 C (77 F), excursions permitted to 15-30 C (50-86 F), [Keep from Freezing, Protect from light]), or be such as to provide reduced logistical burden. In addition, the shelf life should eventually be comparable to that obtained for the ATNAA (i.e., 5 years at controlled room temperature). The Service Member-carried device must be administrable by self- and buddy-aid in Mission Oriented Protective Posture 4 (MOPP-4) over-garments and mask, to a casualty in MOPP-4. 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, to include: - General background information, product name and description, as well as pertinent development efforts needed to encompass delivery of atropine and 2-PAM in a single autoinjector that accounts for bioavailability interactions between the two drugs. - Appropriateness of proposed drug delivery device for military field-use, including: a. Portability of the proposed drug delivery platform 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 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, 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. 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 (email is preferred); (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). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted. Material that is advertisement only in nature is not desired. Please address responses to this notice to the Government Contract Specialist, Jennifer Bassett: jennifer.s.bassett.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 or faxed. 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: Jennifer Bassett 1564 Freedman Drive, Fort Detrick, Maryland 21702. Point of Contact: jennifer.s.bassett.civ@mail.mil Fax #301-619-5069
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/ef50590debeceac95e3e2a4d699fff7f)
- Place of Performance
- Address: ACC-APG - Natick (SPS) ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Zip Code: 01760-5011
- Record
- SN03218661-W 20131020/131018234013-ef50590debeceac95e3e2a4d699fff7f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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