SOURCES SOUGHT
A -- Autoinjector Drug Delivery Device
- Notice Date
- 10/5/2018
- Notice Type
- Sources Sought
- NAICS
- 54171
— Research and Development in the Physical, Engineering, and Life SciencesT
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), 10 General Green Avenue, Building 1, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-18-S-0024
- Archive Date
- 11/6/2018
- Point of Contact
- Leo J. Fratis, Phone: 2405861523
- E-Mail Address
-
leo.j.fratis.civ@mail.mil
(leo.j.fratis.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Request for information 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. Respondents may reply to all 3 sections or selected sections of this RFI. Respondents should include in their response which section(s) they are responding to. The Joint Product Manager - Medical Countermeasure Systems-Chemical Defense Pharmaceuticals (JPM-MCS-CDP) is responsible for the development, procurement, fielding, modernization, and sustainment of medical prophylactic, pre-treatment, and therapeutic medical countermeasures against chemical, biological, radiological and nuclear threats. SECTION 1. Atropine Autoinjector This Request For Information (RFI) is posted to conduct market research for industry capability to perform government requested studies and activities using the 2018 FDA-approved Atropine Injection, 2 mg/0.7 mL, Single-Dose Autoinjector. The device is a single-dose prefilled autoinjector that provides a 1.67 mg dose of Atropine base (equivalent to 2 mg atropine sulfate) in a self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers Atropine in 0.7 mL of sterile pyrogen-free solution containing the inactive ingredients: citric acid and sodium citrate (buffer), glycerin 12.47 mg, and phenol 2.8 mg. The pH range is 4.1-4.5. The 2 mg Atropine autoinjector is supplied as 480 self-contained single-dose autoinjectors per box. The National Drug Code (NDC) is 71053-592-01. The Government is requesting information and non-binding cost estimates from respondents for the following: 1. Description of company's experience and ability to design and conduct studies in accordance with FDA current good manufacturing practice for combination products guidance using the Atropine autoinjector for the following: a. Development of reliability requirement(s) and specification(s) to mitigate the failure to fire risk, evidence to verify and validate the reliability specification(s), and control the reliability of the Atropine autoinjector through design and manufacturing. b. Conduct of human factors validation studies (approx. 30-35 participants, age 18-62) that evaluate critical tasks on the Atropine autoinjector. The users should be outfitted in representative gear (Mission Oriented Protective Posture (MOPP) IV) in a realistic environment that is representative of a real-life scenario. Evaluation factors should include both objective and subjective elements. c. Stability Studies using the Atropine autoinjector performed over 60 months across the range of storage and operational environments including i.e., stored at 20◦C to 25°C (68◦F to 77°F); excursions permitted between 15° to 30°C (59° to 86°F); keep from freezing. 2. Description of company's experience with FDA regulatory activities and current good manufacturing practice requirements for combination products with the Atropine autoinjector including: a. Ability to manage activities related to the development of an Investigation New Drug (IND) application and New Drug Application (NDA) submissions and supplements. Description of experience with submissions in an electronic Common Technical Document (eCTD) format. b. Ability to engage in meetings with the FDA and preparation of pre-meeting information packets. c. Ability to conduct comparative bioavailability and bioequivalence studies d. Ability to conduct autoinjector device testing according MIL-STD 810G. e. Ability to conduct Stability testing at controlled room temperature, operational temperature, and identification of temperature excursion limits. f. Ability translate documentation from Hebrew to English. SECTION 2. Pyridostigmine Bromide This Request For Information (RFI) is posted to conduct market research for industry capability to perform government requested studies and activities using Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP) (Pyridostigmine Bromide, 30 mg) which is an orally active cholinesterase inhibitor and used as a pretreatment for exposure to chemical nerve agents. The Government is requesting information and non-binding cost estimates from respondents for the following: 1. Description of company's experience and ability to design and conduct studies in accordance with FDA current good manufacturing practices (GMP) for SNAPP including: a. Extended stability studies (3 months - 10 years) across a range of temperature, humidity, and storage conditions according to The U.S. Pharmacopeia (USP) <659> "Packaging and Storage Requirements." The following temperature ranges should be considered: i. Room temperature (5 years-10 years): The temperature prevailing in a work area. ii. Controlled room temperature (10 years): The temperature maintained thermostatically that encompasses at the usual and customary working environment of 20°-25° (68°-77 °F). Excursions between 15° and 30° (59° and 86 °F) that are experienced in pharmacies, hospitals, and warehouses, and during shipping are allowed. Provided the mean kinetic temperature does not exceed 25°, transient spikes up to 40° are permitted as long as they do not exceed 24 h. Spikes above 40° may be permitted only if the manufacturer so instructs. iii. Changing from refrigerator to controlled room temperature at 5 years (10 years) iv. Operational shelf-life extension: The temperature maintained in excessive heat which is temperatures above 40° (104 °F). b. Prepare special protocol assessment(s) for stability studies. 2. Description of company's experience with FDA regulatory activities and current good manufacturing practice requirements: a. Ability to manage activities related to the maintenance of an IND application and NDA submissions and supplements. Description of experience with submissions in an eCTD format. b. Ability to engage in meetings with the FDA and preparation of pre-meeting information packets. SECTION 3. Post-marketing Surveillance Activities This Request for Information (RFI) is posted to conduct market research for industry capability to perform government requested studies and activities regarding clinical trials and post-marketing surveillance on FDA approved drug products. The Government is requesting information and non-binding cost estimates from respondents for the following: 1. Description of a company's experience and ability to design, compile, analyze, and prepare a report on confirmatory studies (such as field studies) to determine clinical benefit and assess its safety when used as indicated when such studies are feasible and ethical. The company should provide as a guide standard phase 4 requirements from 3,000 to 5,000 patients for estimating purposes. 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(s); 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 Contracting Officer, Leo Fratis: leo.j.fratis.civ@mail.mil. Please designate a company point of contact (telephone, address, and email). All questions regarding this RFI must be in writing and e-mailed. No telephone inquiries will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/92d1ab61ef8ab34be1a15f03220773c1)
- Record
- SN05117050-W 20181007/181005230342-92d1ab61ef8ab34be1a15f03220773c1 (fbodaily.com)
- Source
-
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