SPECIAL NOTICE
A -- Medical Countermeasure Systems - Chemical Defense Pharmaceuticals (MCS-CDP) REQUEST FOR INFORMATION for Pretreatment to the Chemical Nerve Agent Soman
- Notice Date
- 2/7/2014
- 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
- W911QY14SCDP3
- Archive Date
- 2/7/2015
- 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
- SYNOPSIS: The purpose of this Request For Information (RFI) is to conduct market research for manufacturing capability for a nerve agent pretreatment. The particular pretreatment of interest is pyridostigmine bromide, 30 mg tablets. The Department of Defense (DoD) is seeking industry interest to manufacture this pretreatment in a tablet form for use 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 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 a pretreatment for use prior to exposure to the chemical nerve agent soman, as part of Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP). Each tablet contains 30 mg of pyridostigmine bromide, as an orally active cholinesterase inhibitor, and is supplied in sealed blister or strip packaging within a protective sleeve. The annual estimated quantity under the current contract is 36,000 blister packages containing 21 tablets each (or 756,000 tablets) per year. The current manufacturer of this product is Valeant Pharmaceuticals International and the National Stock Number for the SNAPP product is NSN 6505-01-178-7903. SNAPP is supplied through the Directorate of Medical Materiel, Defense Logistics Agency Troop Support. The U.S. Army Office of The Surgeon General (OTSG) sponsors the SNAPP New Drug Application (NDA), NDA 20,414 approved in February 2003. It is anticipated that interested parties would become either a contract manufacturer under the OTSG NDA, or could potentially submit their own Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA). OBJECTIVE: Currently, MCS-CDP is seeking capabilities from potential sources for production of pyridostigmine bromide, tablets, USP 30 mg. This efficacy of this life-saving pretreatment is dependent upon the rapid use of the nerve agent antidotes atropine and 2-pralidoxime following exposure to soman. System requirements include manufacturing capability to produce pyridostigmine bromide in the doses currently procured by the DoD, to include labeling, packaging and shipping configurations. The storage condition for pyridostigmine bromide tablets, USP, 30 mg, should be identical to SNAPP (i.e., stored at 2-8 C (36-46 F), [Keep from Freezing, Protect from light] or controlled room temperature (20oC-25oC (68oF-77oF)). In addition, the shelf life should eventually be comparable to that obtained for SNAPP (i.e., 10 years at refrigerated temperature or at controlled room temperature for no less than 5 years). As such, MCS-CDP is seeking information on current industry capabilities from interested entities in the following areas: (1) Description of company's technical and regulatory strategy to include: -General background information as well as pertinent development efforts needed to encompass delivery of pyridostigmine bromide in a 30 mg tablet form -Suitability for use across a wide range of temperature and operationally relevant environmental conditions -Summary of existing tablet manufacturing capabilities, annual and surge capacity, and place of manufacture. -Product development, process validation, stability testing, comparative bioavailability and bioequivalence studies, etc. -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 (3) Submit quote mark Draft Product Development Plan Outline quote mark describing any necessary proposed preclinical and/or clinical studies/protocols envisioned to be necessary to submit either a supplemental NDA or an ANDA for pyridostigmine bromide, USP, 30 mg tablets, in a 21 tablets per blister pack configuration. 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, ATTN: Jennifer Bassett 110 Thomas Johnson Drive, Frederick, Maryland 21702. Point of Contact: jennifer.s.bassett.civ@mail.mil
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